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A First Human Dose Study to Investigate Safety and Tolerability of LY2979165 in Healthy Volunteers

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 1
Locations
Singapore
Study Type
Interventional
Intervention
LY2979165
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Are overtly healthy males or females, as determined by medical history and physical examination. Female subjects in Part B are at the site's discretion.
  • Male subjects: Agree to use a reliable method of birth control during the study.
  • Female subjects: Women not of child-bearing potential due to surgical sterilisation (hysterectomy or bilateral oophorectomy or tubal ligation) or postmenopausal as defined by age greater than or equal to 45 years with an intact uterus, who have not taken hormones or oral contraceptives for > 1 year, and either:

    • spontaneous amenorrhea of >12 months, or
    • spontaneous amenorrhea of 6-12 months with a follicle- stimulating hormone (FSH) level of >40 mIU/mL
  • Are between the body mass index (BMI) of 18.5 and 29.9 kg/m2, inclusive.
  • Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator.
  • Have venous access sufficient to allow blood sampling as per the protocol.
  • Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures.
  • Have given written informed consent approved by Lilly and the ethical review board governing the site.

Exclusion Criteria:

  • Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, other than the study drug/device used in this study, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
  • Are persons who have previously completed or withdrawn from this study.
  • History of clinically significant adverse drug reactions or "drug allergy" to more than 3 different types of systemically administered medications or known allergies to LY2979165 or it's constituents.
  • Have a Bazett's corrected QT (QTcB) interval value of >450 msec (males) or >470 msec (females) or any abnormality in the screening 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study.
  • Have an abnormal blood pressure (at least 5 minutes in supine position) as determined by the investigator.
  • Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, immunological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data.
  • Have increased risk of seizures as evidenced by a history of: greater than or equal to 1 seizure (except childhood febrile seizure), history of electroencephalogram with epileptiform activity, history of stroke, surgery to the cerebral cortex, or head trauma with loss of consciousness.
  • Show evidence of significant active neuropsychiatric disease.
  • Have a history of alcohol or drug abuse.
  • Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies.
  • Show evidence of hepatitis B and/or positive hepatitis B surface antigen.
  • Have donated blood of more than 450 mL within the last 3 months prior to dosing.
  • Intended use of over-the-counter medication within 7 days prior to dosing or during the study with the exception of vitamins and mineral supplements (not providing >100% of the recommended dietary allowance [RDA]), or occasional paracetamol or acetaminophen. If this situation arises, inclusion of an otherwise suitable subject may be at the discretion of the sponsor.
  • Intended use of herbal supplements or prescription medications, other than stable doses of thyroid or estrogen hormone replacement, within 14 days prior to dosing or during the study. If this situation arises, inclusion of an otherwise suitable subject may be at the discretion of the sponsor.
  • Subjects who meet at least 1 of the following criteria (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits):

    • subjects who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females),
    • subjects unwilling to stop alcohol consumption 48 hours prior to dosing until the completion of each study appointment, or
    • subjects unwilling to limit alcohol intake to no more than 3 units per day between study appointments.
  • Cigarette consumption of more than 10 cigarettes per day or unable/unwilling to abide by CRU smoking restrictions during admissions.
  • Any other condition, which in the opinion of the investigator, would preclude participation in the study.

In addition for Part B only:

  • Abnormalities in lumbar spine previously known or determined by screening lumbar x-ray.
  • History of clinically significant back pain, back pathology and/or back injury (for example, degenerative disease, spinal deformity or spinal surgery) that may predispose to complications or technical difficulty with lumbar puncture.
  • Have evidence or history of significant active bleeding or coagulation disorder or have taken non-steroidal anti inflammatory drugs (NSAIDs) or other drugs that affect coagulation or platelet function within 14 days prior to lumbar catheter insertion.
  • Have an allergy to lidocaine (Xylocaine®) or its derivatives.
  • Have medical or surgical conditions in which lumbar puncture is contraindicated.
  • Have participated in Part A of this study.

Sites / Locations

  • For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

LY2979165 (Part A)

Placebo (Part A)

LY2979165 - low dose (Part B)

LY2979165 - high dose (Part B)

Placebo - Part B

Arm Description

single oral doses at dose levels ranging from 20 to 1000 mg

single oral dose

single oral low dose of LY297165 (dose to be determined by Part A)

single oral high dose of LY2979165 (dose determined from Part A)

single oral dose

Outcomes

Primary Outcome Measures

Number of participants with clinically significant effects

Secondary Outcome Measures

Pharmacokinetics, area under the concentration curve (AUC), Parts A and B
Pharmacokinetics maximum plasma concentration (Cmax), Parts A and B.
Pharmacokinetics, cerebrospinal fluid area under the concentration curve (AUC), Part B only
Pharmacokinetics, maximum cerebrospinal fluid concentration (Cmax), Part B only

Full Information

First Posted
November 23, 2010
Last Updated
June 24, 2011
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01248052
Brief Title
A First Human Dose Study to Investigate Safety and Tolerability of LY2979165 in Healthy Volunteers
Official Title
Single-Ascending Dose, Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study of LY2979165 in Healthy Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a two part study (Parts A and B), the purpose of which is to determine the safety of LY2979165 in healthy people, and any side effects that might be associated with it, and to understand how the body handles LY2979165. In addition, Part B, will also look at levels of LY2979165 in spinal fluid. Doses investigated will be in the range of 20-1000 mg.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY2979165 (Part A)
Arm Type
Experimental
Arm Description
single oral doses at dose levels ranging from 20 to 1000 mg
Arm Title
Placebo (Part A)
Arm Type
Placebo Comparator
Arm Description
single oral dose
Arm Title
LY2979165 - low dose (Part B)
Arm Type
Experimental
Arm Description
single oral low dose of LY297165 (dose to be determined by Part A)
Arm Title
LY2979165 - high dose (Part B)
Arm Type
Experimental
Arm Description
single oral high dose of LY2979165 (dose determined from Part A)
Arm Title
Placebo - Part B
Arm Type
Placebo Comparator
Arm Description
single oral dose
Intervention Type
Drug
Intervention Name(s)
LY2979165
Intervention Description
administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
administered orally
Primary Outcome Measure Information:
Title
Number of participants with clinically significant effects
Time Frame
predose through 48 hours postdose
Secondary Outcome Measure Information:
Title
Pharmacokinetics, area under the concentration curve (AUC), Parts A and B
Time Frame
predose through 48 hours postdose
Title
Pharmacokinetics maximum plasma concentration (Cmax), Parts A and B.
Time Frame
predose through 48 hours post dose
Title
Pharmacokinetics, cerebrospinal fluid area under the concentration curve (AUC), Part B only
Time Frame
predose through 48 hours postdose
Title
Pharmacokinetics, maximum cerebrospinal fluid concentration (Cmax), Part B only
Time Frame
predose through 48 hours postdose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Are overtly healthy males or females, as determined by medical history and physical examination. Female subjects in Part B are at the site's discretion. Male subjects: Agree to use a reliable method of birth control during the study. Female subjects: Women not of child-bearing potential due to surgical sterilisation (hysterectomy or bilateral oophorectomy or tubal ligation) or postmenopausal as defined by age greater than or equal to 45 years with an intact uterus, who have not taken hormones or oral contraceptives for > 1 year, and either: spontaneous amenorrhea of >12 months, or spontaneous amenorrhea of 6-12 months with a follicle- stimulating hormone (FSH) level of >40 mIU/mL Are between the body mass index (BMI) of 18.5 and 29.9 kg/m2, inclusive. Have clinical laboratory test results within normal reference range for the population or investigator site, or results with acceptable deviations that are judged to be not clinically significant by the investigator. Have venous access sufficient to allow blood sampling as per the protocol. Are reliable and willing to make themselves available for the duration of the study and are willing to follow study procedures. Have given written informed consent approved by Lilly and the ethical review board governing the site. Exclusion Criteria: Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, other than the study drug/device used in this study, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study. Are persons who have previously completed or withdrawn from this study. History of clinically significant adverse drug reactions or "drug allergy" to more than 3 different types of systemically administered medications or known allergies to LY2979165 or it's constituents. Have a Bazett's corrected QT (QTcB) interval value of >450 msec (males) or >470 msec (females) or any abnormality in the screening 12-lead ECG that, in the opinion of the investigator, increases the risks associated with participating in the study. Have an abnormal blood pressure (at least 5 minutes in supine position) as determined by the investigator. Have a history or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological, immunological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the study medication; or of interfering with the interpretation of data. Have increased risk of seizures as evidenced by a history of: greater than or equal to 1 seizure (except childhood febrile seizure), history of electroencephalogram with epileptiform activity, history of stroke, surgery to the cerebral cortex, or head trauma with loss of consciousness. Show evidence of significant active neuropsychiatric disease. Have a history of alcohol or drug abuse. Show evidence of human immunodeficiency virus (HIV) and/or positive human HIV antibodies. Show evidence of hepatitis B and/or positive hepatitis B surface antigen. Have donated blood of more than 450 mL within the last 3 months prior to dosing. Intended use of over-the-counter medication within 7 days prior to dosing or during the study with the exception of vitamins and mineral supplements (not providing >100% of the recommended dietary allowance [RDA]), or occasional paracetamol or acetaminophen. If this situation arises, inclusion of an otherwise suitable subject may be at the discretion of the sponsor. Intended use of herbal supplements or prescription medications, other than stable doses of thyroid or estrogen hormone replacement, within 14 days prior to dosing or during the study. If this situation arises, inclusion of an otherwise suitable subject may be at the discretion of the sponsor. Subjects who meet at least 1 of the following criteria (1 unit = 12 oz or 360 mL of beer; 5 oz or 150 mL of wine; 1.5 oz or 45 mL of distilled spirits): subjects who have an average weekly alcohol intake that exceeds 21 units per week (males) and 14 units per week (females), subjects unwilling to stop alcohol consumption 48 hours prior to dosing until the completion of each study appointment, or subjects unwilling to limit alcohol intake to no more than 3 units per day between study appointments. Cigarette consumption of more than 10 cigarettes per day or unable/unwilling to abide by CRU smoking restrictions during admissions. Any other condition, which in the opinion of the investigator, would preclude participation in the study. In addition for Part B only: Abnormalities in lumbar spine previously known or determined by screening lumbar x-ray. History of clinically significant back pain, back pathology and/or back injury (for example, degenerative disease, spinal deformity or spinal surgery) that may predispose to complications or technical difficulty with lumbar puncture. Have evidence or history of significant active bleeding or coagulation disorder or have taken non-steroidal anti inflammatory drugs (NSAIDs) or other drugs that affect coagulation or platelet function within 14 days prior to lumbar catheter insertion. Have an allergy to lidocaine (Xylocaine®) or its derivatives. Have medical or surgical conditions in which lumbar puncture is contraindicated. Have participated in Part A of this study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9AM - 5PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician
City
Singapore
Country
Singapore

12. IPD Sharing Statement

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A First Human Dose Study to Investigate Safety and Tolerability of LY2979165 in Healthy Volunteers

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