Evaluate the Pharmacokinetics of CC-220 in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared With Healthy Subjects

NCT03824678 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-220-CP-007U1111-1224-6064
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

This is a multicenter, open-label study to assess the PK of a single 1-mg oral dose of CC-220 in subjects with mild, moderate, and severe hepatic impairment, and in matched healthy control subjects with normal hepatic function. Degree of hepatic impairment will be determined during the Screening period by the subject's score according to Child-Pugh Classification Criteria

Conditions

Hepatic Impairment; Healthy Volunteers

Keywords

Hepatic impairment; Healthy Subjects; CC-220; Pharmacokinetics

Outcome Measures

Primary Outcomes (7)

• Pharmacokinetic- AUC0-t

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

  Up to approximately 5 days

• Pharmacokinetic- AUC0-∞

  Estimation of AUC calculated from time zero to infinity

  Up to approximately 5 days

• Pharmacokinetic- Cmax

  Estimation of observed maximum concentration

  Up to approximately Day 1

• Pharmacokinetic- Tmax

  Estimation of time to Cmax

  Up to approximately Day 1

• Pharmacokinetic- t½

  Estimation of terminal elimination half-life

  Up to approximately 5 days

• Pharmacokinetic- CL/F

  Estimation of apparent clearance of drug from plasma after extravascular administration

  Up to approximately 5 days

• Pharmacokinetic- Vz/F

  Estimation of apparent volume of distribution during the terminal phase

  Up to approximately 5 days

Secondary Outcomes (1)

• Adverse Event(s)

  From consent to 28 days after the dose of IP

Study Arms (1)

Administration of CC-220

EXPERIMENTAL

All subjects will receive one 1-mg CC-220 capsule administered orally with approximately 240 mL of non-carbonated, room temperature water, and administered by trained clinical staff.

Drug: CC-220

Interventions

CC-220 DRUG

CC-220

Administration of CC-220

Eligibility Criteria

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

You may qualify if:

• Subjects must satisfy all of the following criteria to be enrolled in the study:
• 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 a male or female ≥ 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.
• Subject agrees to abide by the requirements and restrictions outlined in the CC-220 Pregnancy Prevention Plan for Subjects in Clinical Trials.
• 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 of \> 40 IU/L at Screening).
• Females of childbearing potential (FCBP)1 must have a negative pregnancy test at the Screening and baseline visits. All FCBP must use two effective birth control methods at the same time (for example: birth control pills, condoms, etc.) or practice complete abstinence from sexual contact with a man beginning 28 days before starting study treatment, throughout the entire duration of study treatment and at least 28 days after the end of study treatment with CC-220. The 2 methods of reliable contraception must include 1 highly effective method and 1 additional effective (barrier) method; options are described below:
• Examples of highly effective methods: intrauterine device; hormonal (birth control pills, injections, implants, levonorgestrel-releasing intrauterine system, medroxyprogesterone acetate depot injections, ovulation inhibitory progesterone-only pills \[eg, desogestrel\]); tubal ligation; or partner's vasectomy.
• AND Examples of additional effective methods: Male condom, diaphragm, or cervical cap.
• Male subjects must:
• a. Practice true abstinence2 (which must be reviewed on a monthly basis, as applicable, and source documented) 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 FCBP while participating in the study, and for at least 90 days after the dose of IP, 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 100.4°F), with sitting systolic blood pressure ≥ 90 and ≤ 160 mm Hg, sitting 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.
• Subject has any condition including the presence of laboratory abnormalities, which places the subject at an unacceptable risk if the subject was to participate in the study.
• Subject has any condition that confounds the ability to interpret data from the study.
• Subject is pregnant or breastfeeding or plans to become pregnant during the study or within 28 days of dosing.
• Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the dose administration, or 5 half-lives of that investigational drug, if known (whichever was longer).
• Subject has consumed any medication known to be a moderate or strong CYP3A inducer (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.
• Subject has consumed any medication known to be a moderate or strong CYP3A inhibitor within 7 days prior to dosing. The Indiana University P450 Drug Interactions Flockhart Table™ may be consulted for a list of such medications.
• Subject has consumed grapefruit, grapefruit juice, or any other grapefruit-containing product or oranges, orange juice, or any other product containing and/or made from oranges within 7 days prior to dosing.
• 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 donated blood or plasma within 2 weeks before the 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 the dose administration, or positive drug Screening test reflecting consumption of illicit drugs, unless the positive drug screen is due to prescription drug use that is approved by the Investigator and Celgene's 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 the dose administration, or a positive alcohol screen.
• Subject has a positive result to the test for human immunodeficiency virus (HIV) antibodies at Screening.
• Subject smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).

Sponsors & Collaborators

• Celgene: lead

Study Sites (3)

Clinical Pharmacology of Miami, LLC

Miami, Florida, 33014-3616, United States

Location

Orlando Clinical Research Center OCRC

Orlando, Florida, 32809, United States

Location

The Texas Liver Institute

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Interventions

iberdomide

Study Officials

• Alice Wang, MD

  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: January 9, 2019
• First Posted: January 31, 2019
• Study Start: February 13, 2019
• Primary Completion: June 18, 2019
• Study Completion: June 18, 2019
• Last Updated: July 27, 2020

Record last verified: 2020-07

Locations

US (3)