Study Evaluating Safety and Tolerability of Escalating Single and Multiple Doses of PIPE-791 and Food Effect in Healthy Volunteers
Study Details
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PIPE-791
|
Drug: PIPE-791
Single and multiple ascending oral doses of PIPE-791 tablets.
|
| Placebo Comparator: Placebo
|
Drug: Placebo
Single and multiple ascending oral doses of matching placebo tablets.
|
Outcome Measures
Primary Outcome Measures
- Safety: Treatment-Emergent Adverse Events (TEAE) [Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts]
Number of participants with TEAEs
Secondary Outcome Measures
- Safety: Cardiac repolarization using Fridericia-corrected QT interval (QTcF) [Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts]
Change in mean QTcF
- Pharmacokinetics (PK): Blood concentration levels of PIPE-791 [Baseline to 14 days post dosing for SAD cohorts and 14 days post dosing for MAD cohorts]
- Pharmacokinetics: Urine concentration levels of PIPE-791 [Baseline on day 1 through day 2 for SAD cohorts and from baseline on day 1 through day 7 for MAD cohorts]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female between 18 and 55 years of age (inclusive) at the time of signing informed consent.
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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.
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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:
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Has a current or recurrent disease that could affect the investigational medicinal product or affect clinical or laboratory assessments.
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Experienced a significant systemic illness, as judged by the Investigator, within 30 days of the first dose.
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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.
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History of alcohol or other substance abuse within the 12 months prior to the dosing at the discretion of the Investigator.
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Routine alcohol consumption meeting or exceeding protocol limits.
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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).
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Donated or lost more than 400 mL of blood within 56 days or plasma within 14 days prior to Screening.
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Received an investigational agent within the last 30 days, prior to screening, or five half-lives of the prior investigational agent.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Worldwide Clinical Trials | San Antonio | Texas | United States | 78217 |
Sponsors and Collaborators
- Pipeline Therapeutics, Inc.
Investigators
- Study Director: Stephen Huhn, MD, Pipeline Therapeutics
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PTI-791-101