Study Evaluating the Effects of Food, Cytochrome P450 Inhibition and Induction on the Pharmacokinetics of CC-122

NCT03340662 | Completed Phase 1 FDA Drug

• 2 other identifiers: CC-122-CP-006U1111-1203-1818
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase 1 open-label 4-part study to evaluate the effect of food, cytochrome P450 inhibition and induction on the pharmacokinetics of CC 122 in healthy adult subjects. Approximately 81 subjects will be enrolled. There will be approximately 24 subjects in Part 1 and approximately 19 subjects in Parts 2, 3, and 4, respectively. Subjects may participate in 1 part only.

Conditions

Healthy Volunteer

Keywords

Healthy Volunteer; CC-122; Adult; Phase 1; CYTOCHROME P450

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetic- Cmax

  Observed maximum plasma concentration

  up to approximately 1 month

• Pharmacokinetic- AUC 0-∞

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

  up to approximately 1 month

Secondary Outcomes (1)

• Adverse Events (AEs)

  From enrollment until at least 28 days after completion of treatment

Study Arms (4)

CC-122 Alone under fasted conditions

EXPERIMENTAL

Single oral dose of 3 mg CC-122 administered alone under fasted conditions

Drug: CC-122

CC-122 plus Itraconazole

EXPERIMENTAL

Single oral dose of 3 mg CC-122 alone and with multiple doses of itraconazole.

Drug: CC-122; Drug: Itraconazole

CC-122 plus Fluvoxamine

EXPERIMENTAL

Single oral dose of 3 mg CC-122 alone and with multiple doses of fluvoxamine.

Drug: CC-122; Drug: Fluvoxamine

CC-122 plus Rifampin

EXPERIMENTAL

Single oral dose of 3 mg CC-122 alone and with multiple doses of rifampin

Drug: CC-122; Drug: Rifampin

Interventions

CC-122 DRUG

CC-122

CC-122 Alone under fasted conditions; CC-122 plus Fluvoxamine; CC-122 plus Itraconazole; CC-122 plus Rifampin

Itraconazole DRUG

CYP3A Inhibitor

CC-122 plus Itraconazole

Fluvoxamine DRUG

CYP1A2 Inhibitor

CC-122 plus Fluvoxamine

Rifampin DRUG

CYP3A Inducer

CC-122 plus Rifampin

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• 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 must understand and voluntarily sign an Informed Consent Form (ICF) prior to any study-related assessments/procedures being conducted.
• Subject is ≥ 18 and ≤ 55 years of age at the time of signing the ICF.
• Subject is willing and able to adhere to the study visit schedule and other protocol requirements.
• Subject is in good health as determined by a physical exam at screening.
• Subject agrees to abide by the requirements and restrictions outlined in the CC-122 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 be postmenopausal (defined as 24 consecutive months without menses before screening, with a follicle-stimulating hormone \[FSH\] level of \> 40 IU/L at screening).
• 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 female of childbearing potential (FCBP)3 while participating in the study, during dose interruptions, and for at least 90 days after the last dose of Investigational Product (IP), even if he has undergone a successful vasectomy.
• Subject has body mass index (BMI) ≥ 18 and ≤ 33 kg/m2 at screening.
• Subject has clinical laboratory safety test results that are within normal limits or
• \- considered not clinically significant by the Investigator. Platelet count, absolute neutrophil count, and absolute lymphocyte count must be above the lower limit of normal at screening.
• Subject is afebrile, with supine systolic blood pressure (BP) ≥ 90 and ≤ 140 mmHg, supine diastolic BP ≥ 50 and ≤ 90 mmHg, and pulse rate ≥ 40 and ≤ 110 bpm at screening.
• Subject has a normal or clinically acceptable 12-lead ECG at screening. In addition:

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 at unacceptable risk if he/she were to participate in the study.
• Subject has any condition that confounds the ability to interpret data from the study.
• Subject has any hypersensitivity, allergy, or other contraindication to the components of the CC-122, itraconazole, fluvoxamine, or rifampin formulations used in this study (see IB and product labels for relevant information).
• Subject is a female of childbearing potential, pregnant, or breastfeeding.
• Subject was exposed to an investigational drug (new chemical entity) within 30 days preceding the first dose administration, or five 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 30 days or 5 terminal half-lives (whichever is longer) prior to the first dose administration.
• Subject has used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days prior to the first dose administration.
• Subject has used CYP3A and/or CYP1A2 inducers and/or inhibitors (including St. John's wort) within 30 days prior to the first dose administration.
• Subject has any surgical or medical condition possibly affecting drug absorption, distribution, metabolism and excretion, eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
• Subject donated blood or plasma within 8 weeks before the first 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 \[DSM\]) within 2 years before the first dose administration, or positive drug screening test reflecting consumption of illicit drugs.
• Subject has a history of alcohol abuse (as defined by the current version of the DSM) within 2 years before the first dose administration, or positive alcohol screen.
• Subject has a CYP1A2\*1 allele or a CYP3A4\*22 allele (PARTS 2, 3, AND 4 ONLY).

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

PPD Phase 1 Clinic

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

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

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines; Oximes; Hydroxylamines; Amines; Organic Chemicals; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Leon Carayannopoulos, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2017
• First Posted: November 13, 2017
• Study Start: November 9, 2017
• Primary Completion: January 27, 2018
• Study Completion: January 27, 2018
• Last Updated: January 16, 2019

Record last verified: 2019-01

Locations

US (1)