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Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BYK324677
Sponsored by
Nycomed
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Given written informed consent
  • Healthy male and female subjects. Assessed as healthy based on a screening examination including medical history, physical examination, blood pressure (systolic ≤140 mmHg, diastolic ≤90 mmHg), pulse rate (within 45-95 bpm), ECG assessment, and clinical laboratory results
  • Body mass index (BMI) between ≥18 and ≤28 kg/m², and a body weight ≥60 kg

Exclusion Criteria:

  • History or current evidence of specified diseases
  • History of malignancy in the past 5 years
  • Gain or loss in body weight of more than 5% within the last 2 months or use of weight-loss medication within the last 3 months
  • ECG abnormalities of clinical relevance
  • Suspected hypersensitivity to the trial medication
  • Positive virology tests indicating acute or chronic infections
  • Clinically relevant laboratory parameters outside a specified range
  • Use of specified medications within certain time frames or use of certain co-medications
  • Abuse of alcohol or drugs
  • Dietary habits that would prevent from taking standardised meals
  • Female subjects: positive pregnancy test; lack of medically reliable methods of contraception during the trial
  • Donation of blood
  • Smoking within the last 3 months

Sites / Locations

  • Nycomed Investigational site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

BYK324677

Placebo

Arm Description

Dose group I: total daily dose 2 mg (1 mg BID or 2 mg SID) Dose group II: total daily dose 4 mg (2 mg BID or 4 mg SID) Dose group III: total daily dose 6 mg (3 mg BID or 6 mg SID) In each dose group 12 subjects (8 subjects BYK324677, 4 subjects placebo) are planned. Within each dose group, the subjects will be randomised to either BYK324677 or placebo at a ratio of 2:1. Within each verum group, the subjects will be randomised to one of the 2 treatment sequences (BID/SID or SID/BID, ratio 1:1) and treated in a cross-over manner.

Outcomes

Primary Outcome Measures

Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers.
Safety/tolerability variables: adverse events (AEs), vital signs (BP, pulse rate, body temperature), 12-lead ECG (PQ [=PR], QRS, QT, QTcF and QTcB intervals, heart rate), laboratory parameters including urinalysis.

Secondary Outcome Measures

Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
Pharmacokinetic variables (e.g. AUC, Cmax, tmax, t1/2) of BYK324677 on Day 1 and Day 5 (single dose i.e. after first Investigational medicinal product (IMP) dose vs steady state) as well as on Day 4 and Day 5 (fed vs fasted, respectively).
Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
Pharmacodynamic variables glucose, insulin, glucagon-like peptide 1 and glucagon on Day -1, Day 4 (fed) and Day 5 (fasted).

Full Information

First Posted
June 28, 2011
Last Updated
May 4, 2012
Sponsor
Nycomed
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1. Study Identification

Unique Protocol Identification Number
NCT01386541
Brief Title
Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers
Official Title
Investigation of Safety/Tolerability, Pharmacokinetics and Pharmacodynamics After Multiple Ascending Doses of BYK324677 in Healthy Volunteers. A Monocentre, Placebo-controlled, Cross-over, Double-blind, Randomised Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
September 2011 (Actual)
Study Completion Date
November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nycomed

4. Oversight

5. Study Description

Brief Summary
This monocenter trial is conducted to obtain first data on safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) after multiple ascending doses of BYK324677 in humans. In addition, the trial should provide preliminary information on a possible influence of sex, food intake, and posology (once or twice daily administration of BYK324677) to support the further planning of the drug development programme.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
BYK324677
Arm Type
Active Comparator
Arm Description
Dose group I: total daily dose 2 mg (1 mg BID or 2 mg SID) Dose group II: total daily dose 4 mg (2 mg BID or 4 mg SID) Dose group III: total daily dose 6 mg (3 mg BID or 6 mg SID) In each dose group 12 subjects (8 subjects BYK324677, 4 subjects placebo) are planned. Within each dose group, the subjects will be randomised to either BYK324677 or placebo at a ratio of 2:1. Within each verum group, the subjects will be randomised to one of the 2 treatment sequences (BID/SID or SID/BID, ratio 1:1) and treated in a cross-over manner.
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BYK324677
Intervention Description
capsules, administered orally
Primary Outcome Measure Information:
Title
Assessment of the safety/tolerability of multiple dosing of BYK324677 given once daily (SID) or twice daily (BID) in healthy volunteers.
Description
Safety/tolerability variables: adverse events (AEs), vital signs (BP, pulse rate, body temperature), 12-lead ECG (PQ [=PR], QRS, QT, QTcF and QTcB intervals, heart rate), laboratory parameters including urinalysis.
Time Frame
during screening, clinical part (treatment) and end-of-trial examination (up to 8 weeks)
Secondary Outcome Measure Information:
Title
Exploratory assessment of the pharmacokinetics (PK) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
Description
Pharmacokinetic variables (e.g. AUC, Cmax, tmax, t1/2) of BYK324677 on Day 1 and Day 5 (single dose i.e. after first Investigational medicinal product (IMP) dose vs steady state) as well as on Day 4 and Day 5 (fed vs fasted, respectively).
Time Frame
during Treatment Period 1 and Period 2 (up to 3 weeks)
Title
Exploratory assessment of the pharmacodynamics (PD) of multiple dosing of BYK324677 (SID or BID) under steady state conditions in healthy volunteers.
Description
Pharmacodynamic variables glucose, insulin, glucagon-like peptide 1 and glucagon on Day -1, Day 4 (fed) and Day 5 (fasted).
Time Frame
during Treatment Period 1 and Period 2 (up to 3 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Given written informed consent Healthy male and female subjects. Assessed as healthy based on a screening examination including medical history, physical examination, blood pressure (systolic ≤140 mmHg, diastolic ≤90 mmHg), pulse rate (within 45-95 bpm), ECG assessment, and clinical laboratory results Body mass index (BMI) between ≥18 and ≤28 kg/m², and a body weight ≥60 kg Exclusion Criteria: History or current evidence of specified diseases History of malignancy in the past 5 years Gain or loss in body weight of more than 5% within the last 2 months or use of weight-loss medication within the last 3 months ECG abnormalities of clinical relevance Suspected hypersensitivity to the trial medication Positive virology tests indicating acute or chronic infections Clinically relevant laboratory parameters outside a specified range Use of specified medications within certain time frames or use of certain co-medications Abuse of alcohol or drugs Dietary habits that would prevent from taking standardised meals Female subjects: positive pregnancy test; lack of medically reliable methods of contraception during the trial Donation of blood Smoking within the last 3 months
Facility Information:
Facility Name
Nycomed Investigational site
City
Mannheim
ZIP/Postal Code
68167
Country
Germany

12. IPD Sharing Statement

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Multiple Ascending Dose Trial of BYK324677 in Healthy Volunteers

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