First-in-human Study to Evaluate Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of CC-90001

NCT02110420 | Completed Phase 1

• 1 other identifier: CC-90001-CP-001
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

First-in-human study to evaluate safety, tolerability, and pharmacokinetics of single and multiple ascending doses of CC-90001

Conditions

Healthy Volunteers

Keywords

Safety; Pharmacokinetics; Healthy Subjects; First-in-Human

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Number of participants with adverse events

  Up to 8 months overall

Secondary Outcomes (10)

• Concentrations of CC-90001 in plasma

  Up to 14 days per cohort

• Cmax: Maximum observed plasma concentration

  Up to 14 days per cohort

• Tmax: Time to Cmax

  Up to 14 days per cohort

• AUCinf: Area under the plasma concentration-time curve from time zero extrapolated to infinity

  Up to 14 days per cohort

• AUCt: Area under the plasma concentration-time curve from time zero to the last quantifiable concentration

  Up to 14 days per cohort

Study Arms (14)

CC-90001 10mg (Single Dose)

EXPERIMENTAL

Drug: CC-90001

CC-90001 30mg (Single Dose)

EXPERIMENTAL

Drug: CC-90001

CC-90001 60mg (Single Dose)

EXPERIMENTAL

Drug: CC-90001

CC-90001 120mg (Single Dose)

EXPERIMENTAL

Drug: CC-90001

CC-90001 240mg (Single Dose)

EXPERIMENTAL

Drug: CC-90001

CC-90001 10mg (Multiple Doses)

EXPERIMENTAL

Drug: CC-90001

CC-90001 30mg (Multiple Doses)

EXPERIMENTAL

Drug: CC-90001

CC-90001 60mg (Multiple Doses)

EXPERIMENTAL

Drug: CC-90001

CC-90001 120mg (Multiple Doses)

EXPERIMENTAL

Drug: CC-90001

CC-90001 240mg (Multiple Doses)

EXPERIMENTAL

Drug: CC-90001

Placebo

EXPERIMENTAL

Drug: Placebo

CC-90001 480mg (single dose)

EXPERIMENTAL

CC-90001 480mg will be administered as a single oral dose

Drug: CC-90001

CC-90001 720mg (single dose)

EXPERIMENTAL

CC-90001 720mg will be administered as a single oral dose

Drug: CC-90001

CC-90001 480mg (multiple doses)

EXPERIMENTAL

CC-90001 480mg will be administered daily for 14 days

Drug: CC-90001

Interventions

CC-90001 DRUG

CC-90001 10mg will be administered as a single dose

CC-90001 10mg (Single Dose)

Placebo DRUG

Placebo will be administered once daily for up to 14 days depending on the Part of the study

Placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Must understand and voluntarily sign a written informed consent prior to any study-related procedures being performed.
• \. Must be able to communicate with the investigator, understand and comply with the requirements of the study, and agree to adhere to restrictions and examination schedules.
• \. Healthy male or female of any race between 18 to 50 years of age (inclusive) at the time of signing the informed consent, and in good health as determined by a physical examination at screening.
• \. 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 childbearing potential while on study medication, and for at least 28 days after the last dose of study medication.
• For females: Female subjects must have been surgically sterilized (hysterectomy or bilateral oophorectomy; proper documentation required) at least 6 months before screening, or be postmenopausal (defined as 24 months without menses before screening, with an estradiol level of \< 30 pg/mL and follicle-stimulating hormone level of \> 40 IU/L at screening).
• \. Must have a body mass index between 18 and 33 kg/m2 (inclusive). 6. Platelet count, absolute neutrophil count and absolute lymphocyte count must be above the lower limit of normal at the screening visit.
• \. Liver function tests must be below the upper limit of normal at screening. 8. All other clinical laboratory tests must be within normal limits or acceptable to the investigator.
• \. Subject must be afebrile, with supine systolic blood pressure: 90 to 140 mmHg, supine diastolic blood pressure: 50 to 90 mmHg, and pulse rate: 40 to 110 bpm at screening.
• \. Must have a normal or clinically-acceptable 12-lead electrocardiogram at screening. Male subjects must have a QTcF value ≤ 430 msec. Female subjects must have a QTcF value ≤ 450 msec.

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 or she were to participate in the study, or confounds the ability to interpret data from the study.
• \. 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 is longer).
• \. Used any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 30 days of the first dose administration.
• \. Used any non-prescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
• \. Used cytochrome P450 (CYP)3A inducers and inhibitors (including St. John's Wort) within 30 days of the first dose administration.
• \. Has any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion, for example, bariatric procedure. Appendectomy and cholecystectomy are acceptable.
• \. Donated blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
• \. History of drug abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dosing, or positive drug screening test reflecting consumption of illicit drugs.
• \. History of alcohol abuse (as defined by the current version of the Diagnostic and Statistical Manual) within 2 years before dosing, or positive alcohol screen.
• \. Known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen or hepatitis c antibody, or have a positive result to the test for human immunodeficiency virus antibodies at screening.
• \. Smoke more than 10 cigarettes per day, or the equivalent in other tobacco products (self reported).
• \. History of ulcerative colitis, Crohn's disease, diverticular disease, any polyp(s) along the gastrointestinal tract, or colorectal cancer.
• \. History of hemorrhoids, anal fissures, rectal ulcers, minor rectal bleeding (such as red blood on toilet paper after wiping) within 5 years before the first dose administration.
• \. History of gastrointestinal bleeding or blood in stool within 5 years before the first dose administration.

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (1)

PPD Development, LP

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

CC-90001

Study Officials

• Daniel Weiss, MD

  Celgene Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 12, 2014
• First Posted: April 10, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-10

Locations

US (1)