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Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
PIPE-791
Placebo
Sponsored by
Pipeline Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, PIPE-791, Health volunteers

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Male or female between 18 and 55 years of age (inclusive) at the time of signing informed consent. Male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method 30 days prior to the first dose and up to 90 days post last dose. Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, electrocardiogram (ECG), or laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigatory. Exclusion Criteria: Has a current or recurrent disease that could affect the investigational medicinal product or affect clinical or laboratory assessments. Experienced a significant systemic illness, as judged by the Investigator, within 30 days of the first dose. Has a history of a significant medical, including hepatic and/or renal disease as outlined in the protocol, or psychiatric disorder that may require treatment or make the participant unlikely to fully complete the study or increase risk to the participant. History of alcohol or other substance abuse within the 12 months prior to the dosing at the discretion of the Investigator. Routine alcohol consumption meeting or exceeding protocol limits. History of prior malignancy (except adequately treated non-melanoma skin cancer, carcinoma in-situ of the uterine cervix, ductal carcinoma in situ (DCIS), or localized prostate cancer). Donated or lost more than 400 mL of blood within 56 days or plasma within 14 days prior to Screening. Received an investigational agent within the last 30 days, prior to screening, or five half-lives of the prior investigational agent. Use of any prescription medication, over-the-counter medication, vitamin or supplement, herbal or homeopathic preparation within 7 days or 5 half-lives prior to study drug administration, as determined by the Investigator. Hormone replacement therapy and hormonal contraception is permissible throughout the study.

Sites / Locations

  • Worldwide Clinical TrialsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PIPE-791

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Safety: Treatment-Emergent Adverse Events (TEAE)
Number of participants with TEAEs

Secondary Outcome Measures

Safety: Cardiac repolarization using Fridericia-corrected QT interval (QTcF)
Change in mean QTcF
Pharmacokinetics (PK): Blood concentration levels of PIPE-791
Pharmacokinetics: Urine concentration levels of PIPE-791

Full Information

First Posted
July 19, 2023
Last Updated
July 31, 2023
Sponsor
Pipeline Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05983939
Brief Title
Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers
Official Title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of PIPE_791 and Food Effect in Normal Healthy Volunteers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 26, 2023 (Actual)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pipeline Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD), Part 2 will be a Multiple Ascending Dose (MAD), and Part 3 will be a selected SAD cohort in a fed state. Safety will be assessed by periodic measurement of vital signs, physical examinations, electrocardiograms, blood laboratory analyses and occurrence of adverse events (AE).
Detailed Description
This is a randomized, double-blind study of PIPE-791 or placebo given as single and multiple escalating doses in normal healthy subjects. The study will be conducted in three parts: Part 1 will be a Single Ascending Dose (SAD) study enrolling approximately 48 subjects for a total duration of 6 weeks. Part 2 will be a Multiple Ascending Dose (MAD) study enrolling approximately 32 subjects for a total duration of 7 weeks, and part 3 will be a selected SAD cohort in a fed state to evaluate the effect of food on the bioavailability of PIPE-791, enrolling approximately 8 subjects for a duration of 6 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, PIPE-791, Health volunteers

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
All roles are masked with the exception of the pharmacist/dose preparer.
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PIPE-791
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PIPE-791
Intervention Description
Single and multiple ascending oral doses of PIPE-791 tablets.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Single and multiple ascending oral doses of matching placebo tablets.
Primary Outcome Measure Information:
Title
Safety: Treatment-Emergent Adverse Events (TEAE)
Description
Number of participants with TEAEs
Time Frame
Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts
Secondary Outcome Measure Information:
Title
Safety: Cardiac repolarization using Fridericia-corrected QT interval (QTcF)
Description
Change in mean QTcF
Time Frame
Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts
Title
Pharmacokinetics (PK): Blood concentration levels of PIPE-791
Time Frame
Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts
Title
Pharmacokinetics: Urine concentration levels of PIPE-791
Time Frame
Baseline on day 1 through day 2 for SAD cohorts and from baseline on day 1 through day 7 for MAD cohorts

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female between 18 and 55 years of age (inclusive) at the time of signing informed consent. Male or female subjects with reproductive potential agree to comply with protocol-approved double barrier contraceptive method 30 days prior to the first dose and up to 90 days post last dose. Medically healthy with no clinically significant or relevant abnormalities in medical history, physical exam, vital signs, electrocardiogram (ECG), or laboratory evaluations (hematology, chemistry, and urinalysis) as assessed by the Investigatory. Exclusion Criteria: Has a current or recurrent disease that could affect the investigational medicinal product or affect clinical or laboratory assessments. Experienced a significant systemic illness, as judged by the Investigator, within 30 days of the first dose. Has a history of a significant medical, including hepatic and/or renal disease as outlined in the protocol, or psychiatric disorder that may require treatment or make the participant unlikely to fully complete the study or increase risk to the participant. History of alcohol or other substance abuse within the 12 months prior to the dosing at the discretion of the Investigator. Routine alcohol consumption meeting or exceeding protocol limits. History of prior malignancy (except adequately treated non-melanoma skin cancer, carcinoma in-situ of the uterine cervix, ductal carcinoma in situ (DCIS), or localized prostate cancer). Donated or lost more than 400 mL of blood within 56 days or plasma within 14 days prior to Screening. Received an investigational agent within the last 30 days, prior to screening, or five half-lives of the prior investigational agent. Use of any prescription medication, over-the-counter medication, vitamin or supplement, herbal or homeopathic preparation within 7 days or 5 half-lives prior to study drug administration, as determined by the Investigator. Hormone replacement therapy and hormonal contraception is permissible throughout the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jules Lee
Phone
415-819-0405
Email
jlee@pipeline-tx.com
First Name & Middle Initial & Last Name or Official Title & Degree
Julie Iwashita
Phone
650-813-9981
Email
jiwashita@pipeline-tx.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Huhn, MD
Organizational Affiliation
Pipeline Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Worldwide Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Individual Site Status
Recruiting
Facility Contact:
Phone
210-635-1515
Email
participate@worldwide.com
First Name & Middle Initial & Last Name & Degree
Ellen Remenchik, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers

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