A Study to Assess the Pharmacokinetics of CC-122 in Subjects With Mild, Moderate, and Severe Renal Impairment

NCT03097016 | Completed Phase 1 FDA Drug

• 1 other identifier: CC-122-CP-005
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief Summary

Multi-center, open-label, single-dose study to assess the PK of a single oral dose of 3 mg CC-122 in subjects with mild, moderate, and severe renal impairment as compared to sex, age (± 15 years), and weight (± 20%) matched control subjects with normal renal function.

Conditions

Renal Insufficiency

Keywords

Renal Impairment; Pharmacokinetics; CC-122; Mild; Moderate; Severe

Outcome Measures

Primary Outcomes (9)

• Pharmacokinetics - Tmax

  Time to Observed maximum serum concentration (Cmax)

  up to 72 hours

• Pharmacokinetics - Cmax

  Observed maximum serum concentration (Cmax)

  up to 72 hours

• Pharmacokinetics - AUC0-t

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

  up to 72 hours

• Pharmacokinetics - AUC0-∞

  Area under the serum concentration-time curve calculated from time zero to infinity

  up to 72 hours

• Pharmacokinetics - t1/2

  Terminal elimination half-life

  Up to 72 hours

• Pharmacokinetics - CL/F

  Apparent clearance of drug from serum when dosed orally

  Up to 72 hours

• Pharmacokinetics - Vz/F

  Apparent volume of distribution when dosed subcutaneously during the terminal phase

  Up to 72 hours

• Pharmacokinetics - CLR

  Renal Clearance

  Up to 72 hours

• Pharmacokinetics - Ae

  Amount of excretion

  Up to 72 hours

Secondary Outcomes (1)

• Adverse Events (AEs)

  Up to 40 days

Study Arms (1)

Single oral dose of 3 mg CC-122

EXPERIMENTAL

All subjects will receive one 3 mg CC-122 capsule the morning of Day 1 which will be administered in the fasted state.

Drug: CC-122

Interventions

CC-122 DRUG

All subjects will receive one 3 mg CC-122 capsule the morning of Day 1 which will be administered in the fasted state.

Single oral dose of 3 mg CC-122

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Each subject must satisfy all of the following criteria to be enrolled in the study:
• Subject must understand and voluntarily sign an Informed Consent Form prior to any study-related assessments/procedures being conducted.
• Subject is able to communicate with the Investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules and other protocol requirements.
• Subject is ≥ 18 and ≤ 80 years of age at the time of signing the informed consent.
• Subject has a body mass index between 18 and 40 kg/m2 (inclusive).
• Subject is afebrile
• Subject has a normal or clinically acceptable 12-lead Electrocardiogram at screening. In addition:
• If male, subject has a QTcF value ≤ 470 msec at screening.
• If female, subject has a QTcF value ≤ 480 msec at screening.
• Subject agrees to comply and abide by the requirements and restrictions outlined in the CC-122 Pregnancy Prevention Plan for Subjects in Clinical Trials.
• Female subjects must have been surgically sterilized (hysterectomy, bilateral oophorectomy, proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone level of\> 40 IU/L at screening).
• Male subject must practice true abstinence\* (which must be reviewed on a monthly basis, as applicable) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions (if applicable) and for at least 90 days following study drug discontinuation, even if he has undergone a successful vasectomy.
• True abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject. Period abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
• Each subject with mild, moderate, or severe renal impairment must also meet ALL of the criteria listed below for entry:
• Subject has mild, moderate, or severe (not requiring dialysis) renal impairment as defined by Estimated glomerular filtration rate (eGFR) at screening.

You may not qualify if:

• The presence of any of the following will exclude a subject from enrollment:
• Subject has any condition or circumstance that prevents the subject from understanding and signing the Informed Consent Form.
• Subject has any condition that places the subject at an unacceptable risk from participating in the study or would confound the ability to interpret data from the study.
• Subject has any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, excretion, eg, bariatric procedure. Subjects with cholecystectomy and appendectomy may be included.
• Subject is a female of childbearing potential, pregnant, or breastfeeding.
• Subject donated blood or plasma within 8 weeks before dose administration to a blood bank or blood donation center.
• Subject has a history of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual \[DSM\]) within 6 months before the first dose administration, or positive alcohol screen.
• Subject has a history of drug abuse (as defined by the current version of the DSM) within 6 months before the first dose administration, or positive drug screen that is not consistent with the patient's prescribed medication and or/medical history.
• Subject is known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen (HBsAg), or hepatitis C antibody (HCV Ab) or have a positive result to the test for Human immunodeficiency virus (HIV) antibodies at screening. If a positive result for HCV AB is reported, the Investigator may assess the suitability of the subject based upon normal liver function test results and either no history of Hepatitis C, or documented sustained viral response (ie, undetectable HCV viral load during and 12 weeks after completion of accepted HCV treatment). If the subject meets both criteria, and the Investigator determines this as acceptable, the subject can be considered for enrollment into the trial.
• Subject was exposed to an investigational drug (new chemical entity) within 30 days before dosing, or 5 half-lives of that investigational drug, if known (whichever is longer).
• Subject smokes more than 10 cigarettes per day, or the equivalent in other tobacco products (self-reported).
• Subject has a history of multiple drug allergies or drug-related anaphylaxis.
• Subject used approved medications or herbal medicines that are moderate or strong cytochrome P450 (CYP)1A2 or 3A4/5 inducers and/or inhibitors (including St. John's wort) within 14 days or 5 half-lives of dosing, whichever is longer. The Indiana University "Cytochrome P450 Drug Interaction Table" should be utilized to determine inhibitors and/or inducers of CYP1A2 and CYP3A4/5. (http://medicine.iupui.edu/clinpharm/ddis/table.aspx).
• Subject has received vaccination (excluding seasonal flu vaccination) within 90 days of dosing.
• Subject is part of the staff personnel or a family member of the investigational study staff.

Sponsors & Collaborators

• Celgene: lead

Study Sites (2)

DaVita Clinical Research

Lakewood, Colorado, 80228, United States

Location

DaVita Clinical Research

Minneapolis, Minnesota, 55404, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Lymphoma, Follicular

Interventions

3-(5-amino-2-methyl-4-oxoquinazolin-3(4H)-yl)piperidine-2,6-dione

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Leon Carayannopoulos, 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: March 24, 2017
• First Posted: March 31, 2017
• Study Start: March 30, 2017
• Primary Completion: December 23, 2017
• Study Completion: December 23, 2017
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

US (2)