CC-223 and Ketoconazole Drug-Drug Interaction Study

NCT01896323 | Completed Phase 1

• 1 other identifier: CC-223-CP-003
• Study Type: interventional
• Target: 14
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center open-label study to compare how CC-223 (the study drug being investigated) interacts with the drug ketoconazole.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• Pharmacokinetics

  AUC-area under the plasma concentration-time curve;

  up to 96 hours post dose

• Pharmacokinetics

  Cmax-maximum observed plasma concentration

  up to 96 hours post dose

• Pharmacokinetics

  Tmax - Time to maximum observed plasma concentration

  up to 96 hours post dose

• Pharmacokinetics

  t½ - terminal elimination half-life in plasma

  up to 96 hours post dose

Secondary Outcomes (1)

• Adverse Events

  Up to 28 days after last dose of study drug

Study Arms (2)

CC-223

EXPERIMENTAL

CC-223 administration on study day 1 of Period 1 and study day 5 of Period 2

Drug: CC-223

Ketokonazole

ACTIVE COMPARATOR

Ketoconazole administration on study days 1 through 8 of Period 2

Drug: Ketoconazole

Interventions

CC-223 DRUG

CC-223 20 mg tablets

CC-223

Ketoconazole DRUG

Ketoconazole 400 mg tablets

Also known as: Nizoral

Ketokonazole

Eligibility Criteria

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

You may qualify if:

• Must understand and voluntarily sign a written informed consent form before participation.
• Must be able to communicate with the study doctor, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
• Healthy male subject of any race between 18 to 65 years of age, and in good health as determined by a physical examination.
• \- For males: Agree to use barrier contraception not made of natural (animal) membrane (for example, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of child-bearing potential while on study medication, and for at least 28 days after the last dose of study medication.
• Must have a body mass index between 18 and 33 kilograms/meter squared.
• Clinical laboratory tests must be within normal limits or acceptable to the study doctor.
• Must not have a fever, with a blood pressure between 90/50 to 140/90 millimeters of mercury, and pulse rate: between 40 to 110 beats per minute.
• Must have a normal or clinically acceptable 12-lead electrocardiogram.

You may not qualify if:

• History of any clinically significant and relevant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders.
• Any condition which places the subject at unacceptable risk if he were to participate in the study, or confounds the ability to interpret data from the study.
• Used any prescribed or topical medication within one month before the first dose of study drug, unless consultation between the sponsor and the study doctor.
• Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 2 weeks (30 days for St. John's Wort®) of the first dose administration, unless sponsor agreement is obtained.
• Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion of the study drug, for example, bariatric procedure.
• Donated blood or plasma within 2 months before the first dose of study drug.
• History of drug abuse within 2 years before dosing, or a positive drug screening test reflecting consumption of illicit drugs.
• History of alcohol abuse within 2 years before dosing, or positive alcohol screen.
• Known to have serum hepatitis or known to be a carrier of the hepatitis B surface antigen, or hepatitis C antibody, or have a positive result to the test for Human Immune virus antibodies at Screening.
• Exposed to an investigational drug within one month 30 days before the first dose of study drug.
• Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products.

Sponsors & Collaborators

• Celgene: lead

Related Publications (1)

• Tong Z, Narayanan R, Atsriku C, Nissel J, Li Y, Liu H, Wang X, Surapaneni S. Assessment of drug-drug interaction potential and PBPK modeling of CC-223, a potent inhibitor of the mammalian target of rapamycin kinase. Xenobiotica. 2019 Jan;49(1):54-70. doi: 10.1080/00498254.2018.1424377. Epub 2018 Jan 17.

  PMID: 29297772 BACKGROUND

MeSH Terms

Interventions

CC-223; Ketoconazole

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Edward O'Mara, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2013
• First Posted: July 11, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 12, 2019

Record last verified: 2019-11