A Phase 1 Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200
A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200 Following a Single Oral Dose in Healthy Male Subjects
1 other identifier
interventional
6
1 country
1
Brief Summary
This is a Phase 1, open-label non-randomized, single dose study in healthy male subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2022
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2022
CompletedFirst Posted
Study publicly available on registry
February 14, 2022
CompletedStudy Start
First participant enrolled
February 24, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2022
CompletedAugust 30, 2022
August 1, 2022
28 days
February 3, 2022
August 24, 2022
Conditions
Outcome Measures
Primary Outcomes (9)
Total Radioactivity in Urine and Feces
28 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to infinity [AUC(0-inf)]
28 days
Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to the time of the last quantifiable concentration [AUC(0-tlast)
28 days
Maximum Observed Concentration [C(max)]
28 days
Time to Maximum Concentration [T(max)]
28 days
Apparent Terminal Elimination Half-life [t(1/2)]
28 days
Total Radioactivity in Plasma and Whole Blood
28 days
Ratio for AUC(0-inf) Blood / Plasma
28 days
Ratio for AUC(0-inf) Plasma PBI-200 / Total Radioactivity
28 days
Study Arms (1)
[14C]-PBI-200 Treated
EXPERIMENTAL\[14C\]-labeled PBI-200 will be administered as a single dose
Interventions
Eligibility Criteria
You may qualify if:
- Males, of any race, 18 to 65 years of age as of the dosing day.
- Body mass index between 18.0 and 32.0 kg/m2, inclusive.
- Non-smoking/non-vaping, healthy, with no history of clinically relevant medical illness.
You may not qualify if:
- Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder.
- History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance.
- History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Labcorp Clinical Research Unit Inc
Madison, Wisconsin, 53704, United States
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Pyramid Biosciences
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2022
First Posted
February 14, 2022
Study Start
February 24, 2022
Primary Completion
March 24, 2022
Study Completion
March 24, 2022
Last Updated
August 30, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share