A Phase 1, Open-label Study of the Absorption, Metabolism, and Excretion of [14C] PBI-200

• Sponsor: Pyramid Biosciences (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT05238337
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Anticipated Duration (Days): 28
• Patients Per Site Per Month: 6.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Absorption, Metabolism and Excretion in Healthy Volunteers	Drug: [14C]-PBI-200	Phase 1

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Anticipated Study Start Date: Feb 1, 2022
• Anticipated Primary Completion Date: Mar 1, 2022
• Anticipated Study Completion Date: Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: [14C]-PBI-200 Treated	Drug: [14C]-PBI-200; [14C]-radio-labeled-PBI-200

Outcome Measures

Primary Outcome Measures

1. Total Radioactivity in Urine and Feces [28 days]

2. Area Under the Concentration-Time Curve (AUC) of PBI-200 from time zero to infinity [AUC(0-inf)] [28 days]

3. 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]

4. Maximum Observed Concentration [C(max)] [28 days]

5. Time to Maximum Concentration [T(max)] [28 days]

6. Apparent Terminal Elimination Half-life [t(1/2)] [28 days]

7. Total Radioactivity in Plasma and Whole Blood [28 days]

8. Ratio for AUC(0-inf) Blood / Plasma [28 days]

9. Ratio for AUC(0-inf) Plasma PBI-200 / Total Radioactivity [28 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Labcorp Clinical Research Unit Inc	Madison	Wisconsin	United States	53704

Sponsors and Collaborators

• Pyramid Biosciences

Investigators

• Study Director: Chief Medical Officer, Pyramid Biosciences

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Pyramid Biosciences
• ClinicalTrials.gov Identifier: NCT05238337
• Other Study ID Numbers: PBI-200-104
• First Posted: Feb 14, 2022
• Last Update Posted: Feb 14, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Feb 14, 2022