A Study to Assess Safety, Tolerability, and Pharmacokinetics of CC-92480 Formulations in Healthy Adult Participants

NCT04839809 | Completed Phase 1 FDA Drug

• 1 other identifier: CC-92480-CP-003
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1 study that will be conducted in 2 parts. Participants may participate in 1 part only.

• Part 1 will be a randomized, double-blind, placebo-controlled, single ascending dose study to evaluate the safety, tolerability, and PK of CC-92480-02 (Formulation A) administered orally under fasted conditions in healthy adult participants.
• Part 2 will be a randomized, open-label, 2 × 4 crossover study (Periods 1, 2, 3, and 4) to evaluate the relative bioavailability (RBA) of Formulation A versus Formulation B under fasted conditions and explore safety, tolerability, and PK effects of food on Formulation A and Formulation B in healthy adult participants.

Conditions

Healthy Volunteers

Keywords

Healthy Volunteers; CC-92480; Pharmacokinetics

Outcome Measures

Primary Outcomes (19)

• Pharmacokinetics- Cmax Part 1

  Maximum plasma concentration of drug

  Up to 96 hours after dosing

• Pharmacokinetics- Tmax Part 1

  Time to maximum plasma concentration

  Up to 96 hours after dosing

• Pharmacokinetics- AUC0-∞Part 1

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

  Up to 96 hours after dosing

• Pharmacokinetics- AUC0-t Part1

  Area under the plasma concentration-time curve from time zero to the last observable concentration

  Up to 96 hours after dosing

• Pharmacokinetics- t½ Part 1

  Terminal elimination half-life

  Up to 96 hours after dosing

• Pharmacokinetics- CL/F Part 1

  Apparent total plasma clearance

  Up to 96 hours after dosing

• Pharmacokinetics- Vz/F Part 1

  Apparent volume of distribution

  Up to 96 hours after dosing

• Pharmacokinetics- tlag Part 1

  Lag time between time of administration and start of absorption

  Up to 96 hours after dosing

• Pharmacokinetics- Cmax Part 2

  Maximum plasma concentration of drug

  Up to 96 hours after dosing

• Pharmacokinetics- Ratio of Cmax (Formulation A/Formulation B) Part 2

  Ratio of maximum plasma concentration of drug

  Up to 96 hours after dosing

• Pharmacokinetics- AUC0-∞ Part 2

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

  Up to 96 hours after dosing

• Pharmacokinetics- Ratio of AUC0-∞ (Formulation A/Formulation B) Part 2

  Ratio of area under the plasma concentration-time curve from time zero to infinity

  Up to 96 hours after dosing

• Pharmacokinetics- AUC0-t Part 2

  Area under the plasma concentration-time curve from time zero to the last observable concentration

  Up to 96 hours after dosing

• Pharmacokinetics- AUC0-t (Formulation A/Formulation B) Part 2

  Area under the plasma concentration-time curve from time zero to the last observable concentration

  Up to 96 hours after dosing

• Pharmacokinetics- Tmax Part 2

  Time to maximum plasma concentration

  Up to 96 hours after dosing

• Pharmacokinetics- t½ Part 2

  Terminal elimination half-life

  Up to 96 hours after dosing

• Pharmacokinetics- CL/F Part 2

  Apparent total plasma clearance

  Up to 96 hours after dosing

• Pharmacokinetics- Vz/F Part 2

  Apparent volume of distribution

  Up to 96 hours after dosing

• Pharmacokinetics- tlag Part 2

  Lag time between time of administration and start of absorption

  Up to 96 hours after dosing

Secondary Outcomes (24)

• Pharmacokinetics- Cmax (high-fat meal)

  Up to 96 hours after dosing

• Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (high-fat meal)

  Up to 96 hours after dosing

• Pharmacokinetics- AUC0-∞(high-fat meal)

  Up to 96 hours after dosing

• Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞ (high-fat meal)

  Up to 96 hours after dosing

• Pharmacokinetics- AUC0-t (high-fat meal)

  Up to 96 hours after dosing

Study Arms (5)

CC-92480-02 (Formulation A) with Placebo

EXPERIMENTAL

CC-92480-02 (Formulation A) or matching placebo to be administered orally under fasted conditions.

Drug: CC-92480; Other: Placebo

CC-92480 (Formulation B)- fasted condition

EXPERIMENTAL

A single oral dose of CC-92480 (Formulation B) administered under fasted conditions.

Drug: CC-92480

CC-92480-02 (Formulation A) - fasted condition

EXPERIMENTAL

A single oral dose of CC-92480-02 (Formulation A) administered under fasted conditions.

Drug: CC-92480

CC-92480 (Formulation B) - Low-fat meal

EXPERIMENTAL

A single oral dose of CC-92480 (Formulation B) administered under fed conditions (low-fat meal).

Drug: CC-92480

CC-92480-02 (Formulation A) - high-fat meal

EXPERIMENTAL

A single oral dose of CC-92480-02 (Formulation A) administered under fed conditions (high-fat meal).

Drug: CC-92480

Interventions

CC-92480 DRUG

Oral

CC-92480 (Formulation B) - Low-fat meal; CC-92480 (Formulation B)- fasted condition; CC-92480-02 (Formulation A) - fasted condition; CC-92480-02 (Formulation A) - high-fat meal; CC-92480-02 (Formulation A) with Placebo

Placebo OTHER

Oral

CC-92480-02 (Formulation A) with Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must satisfy the following criteria to be enrolled in the study:
• Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being conducted.
• Healthy adult female of nonchildbearing potential or male of any race, between 18 to 55 years of age (inclusive) at the time of signing the ICF, and in good health as determined by the screening history and Physical examination (PE).
• Agrees to abide by the requirements and restrictions outlined in the CC-92480 Pregnancy Prevention Plan for Participants in Clinical Trials.
• For males:
• a. Practice true abstinence (which must be reviewed on a monthly basis, as applicable) or agree to use a barrier contraception not made of natural (animal) membrane (eg, latex or polyurethane condoms are acceptable) when engaging in sexual activity with a female of childbearing potential (FCBP) while on study medication, and for at 3 months after the last dose of study medication even if he has undergone a successful vasectomy.
• For females:
• Female participants 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 a serum follicle-stimulation hormone (FSH) level of \> 40 IU/L at screening.
• Must have a body mass index between 18 and 33 kg/m2 (inclusive) at the time of signing the ICF.
• Clinical laboratory test results must be within the respective reference ranges; or if not, the results be clinically insignificant according to the Investigator's medical judgment.
• Participant must agree and be willing to consume a standard high-fat meal (which may contain gluten), for Part 2 participants only.

You may not qualify if:

• The presence of any of the following will exclude a participant from enrollment:
• Female of childbearing potential, pregnant, or breastfeeding.
• History of any clinically significant and relevant neurological, gastrointestinal (GI), renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders as determined by the Investigator.
• History of severe (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous) reaction to a drug, or adverse reactions to multiple drugs.
• Use of any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 28 days of the first dose administration.
• Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
• Donation of 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 \[DSM\]) within 2 years before first dose administration, or positive drug screening test reflecting consumption of illicit drugs.
• History of alcohol abuse (as defined by the current version of the DSM) within 2 years before first dose administration, or positive alcohol screen.
• Known to have serum hepatitis or known to be a carrier of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (HCV Ab), or have a reactive result to the test for human immunodeficiency virus (HIV) antibodies at screening.
• Use of tobacco- or nicotine-containing products within 3 months prior to Day -1, as assessed by medical history and physical examination, or positive urine cotinine test at screening.
• Vaccination within 30 days of first dose administration or plans to receive vaccination (live and attenuated) within 30 days after dosing.

Sponsors & Collaborators

• Celgene: lead

Study Sites (1)

PPD Phase 1 Clinic

Austin, Texas, 78744, United States

Location

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: January 19, 2021
• Primary Completion: October 8, 2021
• Study Completion: October 8, 2021
• Last Updated: December 10, 2021

Record last verified: 2021-12

Locations

US (1)