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

This is a Phase 1, open-label non-randomized, single dose study in healthy male subjects.

Study Overview

• Status: Completed
• Conditions: Absorption, Metabolism and Excretion in Healthy Volunteers
• Intervention / Treatment: Drug: [14C]-PBI-200

Detailed Description

This is a Phase 1, open-label nonrandomized, single dose study in healthy male subjects to determine the absorption, metabolism, and excretion (AME) of [14C]-PBI-200

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Labcorp Clinical Research Unit Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Key Inclusion Criteria:

• 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.

Key Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-PBI-200 Treated; [14C]-labeled PBI-200 will be administered as a single dose	Drug: [14C]-PBI-200; [14C]-radio-labeled-PBI-200

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Pyramid Biosciences

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2022
• Primary Completion (Actual): March 24, 2022
• Study Completion (Actual): March 24, 2022

Study Registration Dates

• First Submitted: February 3, 2022
• First Submitted That Met QC Criteria: February 3, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 24, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PBI-200-104

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No