A Study to Evaluate the Metabolism and Excretion of [14C]-CC-92480 in Healthy Male Participants

NCT04560738 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-92480-CP-004U1111-1257-8762
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label study to be conducted in healthy adult male participants. This study is designed to characterize the biotransformation and excretion of \[14C\]-CC-92480 and to evaluate the safety and tolerability of \[14C\]-CC-92480 following a single oral dose of \[14C\]-CC-92480.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; CC-92480; Healthy male

Outcome Measures

Primary Outcomes (9)

• Cumulative excretion of [14C]-RA

  The total recovery of radioactivity (RA) will be computed as the sum of the cumulative excretion (as % dose) in urine and feces (and vomit, if applicable).

  Up to approximately 15 days

• Pharmacokinetics -Tmax of total radioactivity, CC-92480 and its metabolites

  Time to reach maximum total radioactivity or concentration of CC-92480 and its metabolites

  Up to approximately 15 days

• Pharmacokinetics - Cmax of total radioactivity, CC-92480 and its metabolites

  Maximum total radioactivity or concentration of CC-92480 and its metabolites

  Up to approximately 15 days

• Pharmacokinetics - AUC0-t of total radioactivity, CC-92480 and its metabolites

  Area under the concentration-time curve from time zero to the last measured time point

  Up to approximately 15 days

• AUC0-inf of total radioactivity, CC-92480 and its metabolites

  Area under the concentration-time curve from time zero extrapolated to infinite time

  Up to approximately 15 days

• Pharmacokinetics - CL/F of total radioactivity, CC-92480 and its metabolites

  Apparent oral clearance

  Up to approximately 15 days

• Pharmacokinetics - Vz/F of total radioactivity, CC-92480 and its metabolites

  Apparent volume of distribution

  Up to approximately 15 days

• Pharmacokinetics - t1/2 of total radioactivity, CC-92480 and its metabolites

  Terminal elimination half-life

  Up to approximately 15 days

• Metabolic profiling in urines and feces

  The percentage of the administered dose attributed to CC-92480 and its metabolites in urine and feces

  Up to approximately 15 days

Secondary Outcomes (1)

• Adverse Events (AEs)

  From enrollment until at least 28 days after completion of study treatment

Study Arms (1)

Administration of [14C]-CC-92480

EXPERIMENTAL

\[14C\]-CC-92480 will be administered as an oral solution. A single oral dose of \[14C\]-CC-92480, containing approximately 2 μCi of radioactivity, will be administered on Day 1 under fasted conditions.

Drug: [14C]-CC-92480

Interventions

[14C]-CC-92480 DRUG

Oral

Administration of [14C]-CC-92480

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must satisfy the following criteria to be enrolled in the study:
• Participant is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
• Participant is male.
• Participant must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Participant is willing and able to adhere to the study visit schedule and other protocol requirements.
• Participant is in good health, as determined by the Investigator at the time of signing the ICF.
• Participant agrees to abide by the requirements and restrictions outlined in the CC-92480 Pregnancy Prevention Plan for Participants in Clinical Trials.
• Participant must practice true abstinence or agree to use a barrier method of birth control (condoms not made out of natural \[animal\] membrane \[latex condoms are recommended\]) during sexual contact with a pregnant female or a FCBP while participating in the study and for at least 90 days following administration of CC-92480, even if he has undergone a successful vasectomy. A FCBP is a female who: 1) has achieved menarche at some point; 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (ie, has had menses at any time in the preceding 24 consecutive months).
• Participant has a body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at the time of signing the ICF.
• Participant has clinical laboratory safety test results, including alanine aminotransferase (ALT)/aspartate aminotransferase (AST) results, that are within normal limits or considered not clinically significant by the Investigator.
• Platelet count and absolute lymphocyte count (ALC) must be above the lower limit of normal at screening.
• Absolute neutrophil counts (ANC) must be greater than 2500/microliter.
• Participant is afebrile, with supine systolic BP ≥ 90 and ≤ 140 mm Hg, supine diastolic BP ≥ 50 and ≤ 90 mm Hg, and pulse rate ≥ 40 and ≤ 110 bpm at screening.
• Participant has a normal or clinically acceptable 12-lead ECG, with a QT interval corrected for heart rate using Fridericia's formula (QTcF) value ≤ 430 msec, at screening.

You may not qualify if:

• The presence of any of the following will exclude a participant from enrollment:
• Participant has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the participant from participating in the study.
• Participant has a history of chronic pruritus or clinically significant chronic dermatologic disorder.
• Participant has contraindication or intolerance to first-generation antihistamine medications.
• Participant has a history of benign ethnic neutropenia.
• Participant has a history of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders as determined by the Investigator.
• Participant has any condition, including the presence of laboratory abnormalities, which places the participant at unacceptable risk if he were to participate in the study.
• Participant has any condition that confounds the ability to interpret data from the study.
• Participant was exposed to an investigational drug (new chemical entity) within 30 days prior to dosing or 5 half-lives of that investigational drug, if known (whichever is longer).
• Participant has used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 14 days or 5 half-lives of that medication, whichever is longer, prior to dosing.
• Participant has used any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines) within 7 days prior to dosing.
• Participant has used CYP3A inducers and/or inhibitors (including St. John's Wort) within 30 days prior to dosing. The Indiana University "Cytochrome P450 Drug Interaction Table" should be utilized to determine inducers and/or inhibitors of CYP3A (http://medicine.iupui.edu/clinpharm/ddis/table.aspx).
• Participant has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure.
• Participant donated blood or plasma within 8 weeks prior to dosing to a blood bank or blood donation center.
• Participant has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual \[DSM\]) within 2 years prior to dosing, or positive drug test reflecting consumption of illicit drugs.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Covance Clinical Research Unit Inc

Madison, Wisconsin, 53704, United States

Location

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2020
• First Posted: September 23, 2020
• Study Start: October 15, 2020
• Primary Completion: May 13, 2021
• Study Completion: May 13, 2021
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

US (1)