A Study to Assess the Pharmacokinetics of CC-90001 in Subjects With Mild, Moderate, and Severe Hepatic Impairment Compared With Healthy Subjects

NCT03742882 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-90001-CP-005U1111-1223-7431
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 4

Brief Summary

This is a multicenter, open-label study to assess the PK of a single 200 mg oral dose of CC-90001 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degrees of hepatic impairment will be determined during screening by the subject's score according to Child-Pugh Classification Criteria.

Conditions

Hepatic Impairment

Keywords

CC-90001; Pharmacokinetics; Hepatic Impairment; Healthy subjects

Outcome Measures

Primary Outcomes (7)

• Pharmacokinetic- AUC0-t

  Estimation of AUC calculated from time zero to the last measured time point

  UP to approximately 7 Days

• Pharmacokinetic- AUC0-∞

  Estimation of AUC calculated from time zero to infinity

  UP to approximately 7 Days

• Pharmacokinetic- Cmax

  Estimation of observed maximum plasma concentration

  UP to approximately Day 1

• Pharmacokinetic- Tmax

  Estimation of time to Cmax

  UP to approximately Day 1

• Pharmacokinetic- t1/2

  Estimation of terminal elimination half-life

  Up to approximately 7 days

• Pharmacokinetic- CL/F

  Estimation of apparent clearance of drug from plasma after extravascular administration

  Up to approximately 7 days

• Pharmacokinetic- Vz/F

  Estimation of apparent volume of distribution during the terminal phase

  Up to approximately 7 days

Secondary Outcomes (1)

• Adverse Events (AEs)

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

Study Arms (1)

Administration of CC-90001

EXPERIMENTAL

Single oral dose of 200 mg of CC-90001

Drug: CC-90001

Interventions

CC-90001 DRUG

CC-90001

Administration of CC-90001

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject must understand and voluntarily sign an Informed Consent Form (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, including the restrictions.
• Subject is male, or non-pregnant and non-nursing female between ≥ 18 and ≤ 70 years of age at the time of signing the ICF.
• Subject has Body mass index (BMI) ≥ 18 and ≤ 40 kg/m2 at screening.
• Female subjects NOT of childbearing potential must:
• a. Have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before Screening, or postmenopausal (defined as 24 consecutive months without menses before Screening, with a follicle-stimulating hormone \[FSH\] level in the postmenopausal range according to the laboratory used at Screening); FSH to be performed at the discretion of the Investigator in consultation with the Medical Monitor.
• Females of childbearing potential (FCBP)1 must have a negative pregnancy test at the Screening and Baseline Visits. While receiving Investigational Product (IP) and for at least 28 days after taking the dose of IP, FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options described below: Option 1: One highly effective method (e.g., hormonal contraception \[oral, injection, implant, transdermal patch, vaginal ring\]; intrauterine device; tubal ligation; or partner's vasectomy) and one additional form (latex condom or any nonlatex condom not made of natural \[animal\] membrane \[eg, polyurethane\], diaphragm, sponge).
• OR Option 2: Male or female condom PLUS 1 additional barrier method: (a) diaphragm with spermicide; (b) cervical cap with spermicide; or (c) contraceptive sponge with spermicide.
• Male subjects must:
• a. Practice true abstinence2 (which must be reviewed on a monthly basis and source documented) or agree to use a barrier method of birth control (condoms not made out of natural \[animal\] membrane \[latex condoms were recommended\]) during sexual contact with a pregnant female or female of FCBP while participating in the study, during dose interruptions, and for at least 28 days after the dose of investigational product, even if he has undergone a successful vasectomy.
• Subject has clinical laboratory safety test results that are within normal limits or acceptable to the Investigator.
• Subject is afebrile (febrile is defined as ≥ 38°C or 100.3°F), with supine systolic blood pressure ≥ 90 and ≤ 160 mm Hg, supine diastolic blood pressure ≥ 50 and ≤ 100 mm Hg, and pulse rate ≥ 40 and ≤ 100 beats per minute at Screening.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subject has any significant and relevant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from participating in the study at the Investigator's discretion.
• Subject has any condition that places the subject at an unacceptable risk if he or she were to participate in the study.
• Subject has any condition that confounds the ability to interpret data from the study.
• Subject is pregnant or breastfeeding.
• Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or 5 half-lives of that investigational drug, if known (whichever was longer).
• Subject has used moderate or strong CYP3A4/5 inducers and/or inhibitors (including St. John's wort) within 30 days prior to dosing. The Indiana University P450 Drug Interactions Flockhart Table™ may be consulted for a list of such medications (http://medicine.iupui.edu/clinpharm/ddis/main-table).
• Subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion, eg, bariatric procedure. Subjects with appendectomy and cholecystectomy may be included.
• Subject has an estimated creatinine clearance \< 60 mL/min as calculated using the Cockcroft-Gault formula.
• Subject has donated blood or plasma within 2 weeks before dose administration to a blood bank or blood donation center.
• Subject has a history of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dose administration, or positive drug screening test reflecting consumption of illicit drugs unless positive drug screen is due to prescription drug use that is approved by the Investigator and the Medical Monitor.
• Subject has a history of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 1 year before dose administration, or a positive alcohol screen.
• Subject has had a positive result to the test for human immunodeficiency virus (HIV) antibodies at Screening.
• Chronic or resolved Hepatitis B or Hepatitis C are acceptable only if sequelae are limited to hepatic involvement and its consequent comorbidities. (ie, vasculitis, clinically significant globulinemia, etc. are unacceptable).
• Subject smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).

Sponsors & Collaborators

• Celgene: lead

Study Sites (4)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Orlando Clinical Research Center OCRC

Orlando, Florida, 32809, United States

Location

Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, 37920, United States

Location

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Interventions

CC-90001

Study Officials

• Kofi Mensah, MD, PhD

  Celgene

  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: November 13, 2018
• First Posted: November 15, 2018
• Study Start: December 6, 2018
• Primary Completion: June 10, 2019
• Study Completion: June 10, 2019
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

US (4)