A Study to Evaluate the Metabolism and Excretion of [14C]-CC-90009 in Healthy Male Subjects

NCT04297124 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-90009-CP-001U1111-1248-0508
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

CC-90009-CP-001 is a Phase 1, single-center, open-label, clinical pharmacology study to measure how much CC 90009 gets into the bloodstream, how much is eliminated in urine and stool, and how long it takes the body to get rid of it. In addition, the safety and tolerability of CC 90009 will be evaluated.

Conditions

Healthy Volunteer

Keywords

CC-90009; Metabolism; Healthy Male

Outcome Measures

Primary Outcomes (7)

• Pharmacokinetics - Total [14C]- radioactivity (RA)

  Total \[14C\]-RA in whole blood, plasma, urine, and feces will be measured via LC-AMS

  pre-dose to 240 hours post-dose

• Pharmacokinetics - Cumulative excretion of total [14C]-RA

  Total RA recovery will be computed as the sum of the cumulative excretion (as % dose) in urine and feces.

  pre-dose to 240 hours post-dose

• Pharmacokinetics - Total [14C]-RA whole blood-to-plasma ratios

  Ratio of total RA recovery in whole blood compared to in plasma

  pre-dose to 120 hours post-dose

• Pharmacokinetics - Cmax

  Observed maximum concentration

  pre-dose to 240 hours post-dose

• Pharmacokinetics - AUC

  Area under the concentration

  pre-dose to 240 hours post-dose

• Pharmacokinetics - Tmax

  Time to Cmax.

  pre-dose to 240 hours post-dose

• Pharmacokinetics - t1/2

  Terminal elimination half-life

  pre-dose to 240 hours post-dose

Secondary Outcomes (1)

• Adverse Events (AEs)

  From the time of informed consent until 28 days after the last dose of study drug.

Study Arms (1)

[14C]-CC-90009

EXPERIMENTAL

A single IV dose of 0.6 mg \[14C\]-CC-90009 containing approximately 2 µCi of radioactivity will be administered on Day 1 under fasted conditions.

Drug: CC-90009; Radiation: [14C]

Interventions

CC-90009 DRUG

0.6 mg \[ 14C\]-CC-90009 administered IV as a single dose

[14C]-CC-90009

[14C] RADIATION

A single dose of \[ 14C\]-CC-90009 will contain approximately 2 µCi of radioactivity.

[14C]-CC-90009

Eligibility Criteria

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

You may qualify if:

• Subjects must satisfy the following criteria to be enrolled in the study:
• Subject is ≥ 18 and ≤ 55 years of age at the time of signing the informed consent form (ICF).
• Subject is male.
• Subject must understand and voluntarily sign an ICF prior to any study-related assessments/procedures being conducted.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• Subject is in good health, as determined by the Investigator based on a physical examination at screening.
• Subject agrees to abide by the requirements and restrictions outlined in the CC-90009 Pregnancy Prevention Plan for Subjects in Clinical Trials.
• All subjects must avoid donating semen or sperm and practice complete abstinence (True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence \[eg calendar, ovulation, symptothermal or post ovulation methods\] and withdrawal are not acceptable methods of contraception.) or condom use during sexual contact with a pregnant female or a female of childbearing potential (FCBP) while receiving CC-90009 and for at least 28 days after the dose, even if he has undergone a successful vasectomy. If engaging in sexual contact, inform their partners who are FCBP to use two methods of reliable contraception, one highly effective and one additional effective, throughout the entire duration of CC-90009 and for at least 28 days after their dose of CC-90009. Partners of male subjects who are females of childbearing potential must use contraception during the same duration as the male subject to avoid pregnancy. If a pregnancy occurs with your partner, notify the doctor conducting the study immediately. The following are examples of highly effective and additional effective methods of contraception:
• Examples of highly effective methods:
• Intrauterine device (IUD)
• Hormonal (birth control pills, injections, implants, levonorgestrel-releasing intrauterine system \[IUS\], medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills \[e.g. desogestrel\])
• Tubal ligation
• Partner's vasectomy
• Examples of additional effective methods:
• Male condom

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subject has any significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study.
• Subject has any condition including the presence of laboratory abnormalities, which places the subject or other study participants at unacceptable risk if he were to participate in the study.
• Subject has a past or current history of any condition affecting calcium homeostasis including, but not limited to: hypocalcemia, parathyroid disorders, vitamin D level lower than 20 ng/mL, disorders of phosphate or magnesium metabolism. The Investigator should contact the Sponsor for questions on any disorders that may be related to calcium homeostasis. Subjects with vitamin D levels \< 30 ng/mL are not permitted to serve as sentinel subjects or alternates for the sentinel subjects.
• Subject has a history of prior infusion reactions, anaphylactic reactions, or anaphylactoid reactions to any medication regardless of severity.
• Subject participated in a radiolabeled drug study, where exposures either are known or unknown to the Investigator, within the previous 12 months prior to Day -1. The total 12-month exposure from this study and a maximum of 2 other previous studies within 4 to 12 months of this study will be within the CFR recommended levels considered safe, per US Title 21 CFR 361.1: less than 5,000 mrem whole body annual exposure, with consideration given to the half-lives of the previous radiolabeled study drugs received.
• Subject was exposed to significant radiation (eg, serial X-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring) within 12 months prior to Day -1. All questions regarding this criterion should be discussed with the Sponsor.
• History of less than 1 to 2 bowel movements per day.
• Subject is unable to take calcium citrate, vitamin D3, Dulcolax®, acetaminophen or diphenhydramine because of allergy or other intolerance.
• Subject has any condition that confounds the ability to interpret data from the study. The Investigator should contact the Sponsor for questions about eligibility based on this criterion.
• Subject 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).
• Subject 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.
• Subject has used any non-prescribed systemic or topical medication (including vitamin/mineral supplements and herbal medicines) within 7 days prior to dosing.
• Subject has used cytochrome P (CYP) 450 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 CYP (http://medicine.iupui.edu/clinpharm/ddis/table.aspx).
• Subject donated blood or plasma within 8 weeks prior to dosing to a blood bank or blood donation center.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

Covance Clinical Research Unit Inc.

Madison, Wisconsin, 53704, United States

Location

MeSH Terms

Interventions

CC-90009

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

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: March 4, 2020
• First Posted: March 5, 2020
• Study Start: March 11, 2020
• Primary Completion: June 4, 2021
• Study Completion: June 4, 2021
• Last Updated: December 17, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: See Plan Description
• Access Criteria: See Plan Description

Locations

US (1)