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Completed

NCT Number: NCT05238337

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

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

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Key information

Conditions

Absorption, Metabolism and Excretion in Healthy Volunteers

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Clinical Research Unit Inc

Madison, Wisconsin, 53704, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

[14C]-PBI-200

Drug

[14C]-radio-labeled-PBI-200

Primary outcomes

  1. Total Radioactivity in Urine and Feces

    Time frame: 28 days

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

    Time frame: 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)

    Time frame: 28 days

  4. Maximum Observed Concentration [C(max)]

    Time frame: 28 days

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

    Time frame: 28 days

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

    Time frame: 28 days

  7. Total Radioactivity in Plasma and Whole Blood

    Time frame: 28 days

  8. Ratio for AUC(0-inf) Blood / Plasma

    Time frame: 28 days

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

    Time frame: 28 days

Sponsors and collaborators

Lead sponsor

Pyramid Biosciences

Industry

Registry information

Official study 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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 14, 2022
Registry last updated
Aug 30, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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