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

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: CC-92480; Other: Placebo

• Registration Number: NCT04839809
• Lead Sponsor: Celgene

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-19
• Study First Submitted: 2021-04-07
• Study First Submitted QC: 2021-04-07
• Study First Posted: 2021-04-09
• Primary Completion: 2021-10-08
• Study Completion: 2021-10-08
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-08
• Last Update Posted: 2021-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Participants must satisfy the following criteria to be enrolled in the study:

1. Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/procedures being conducted.

2. 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).

3. Agrees to abide by the requirements and restrictions outlined in the CC-92480 Pregnancy Prevention Plan for Participants in Clinical Trials.

4. 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.

5. 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.

6. Must have a body mass index between 18 and 33 kg/m2 (inclusive) at the time of signing the ICF.

7. 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.

8. Participant must agree and be willing to consume a standard high-fat meal (which may contain gluten), for Part 2 participants only.

Exclusion Criteria

The presence of any of the following will exclude a participant from enrollment:

1. Female of childbearing potential, pregnant, or breastfeeding.
2. 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.
3. History of severe (eg, anaphylactic, anaphylactoid, Stevens-Johnson, angioedematous) reaction to a drug, or adverse reactions to multiple drugs.
4. Use of any prescribed systemic or topical medication (including but not limited to analgesics, anesthetics, etc) within 28 days of the first dose administration.
5. Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
6. Donation of blood or plasma within 8 weeks before the first dose administration to a blood bank or blood donation center.
7. 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.
8. History of alcohol abuse (as defined by the current version of the DSM) within 2 years before first dose administration, or positive alcohol screen.
9. 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.
10. 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.
11. Vaccination within 30 days of first dose administration or plans to receive vaccination (live and attenuated) within 30 days after dosing.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CC-92480-02 (Formulation A) - high-fat meal	CC-92480	A single oral dose of CC-92480-02 (Formulation A) administered under fed conditions (high-fat meal).
CC-92480-02 (Formulation A) with Placebo	Placebo	CC-92480-02 (Formulation A) or matching placebo to be administered orally under fasted conditions.
CC-92480-02 (Formulation A) with Placebo	CC-92480	CC-92480-02 (Formulation A) or matching placebo to be administered orally under fasted conditions.
CC-92480 (Formulation B)- fasted condition	CC-92480	A single oral dose of CC-92480 (Formulation B) administered under fasted conditions.
CC-92480-02 (Formulation A) - fasted condition	CC-92480	A single oral dose of CC-92480-02 (Formulation A) administered under fasted conditions.
CC-92480 (Formulation B) - Low-fat meal	CC-92480	A single oral dose of CC-92480 (Formulation B) administered under fed conditions (low-fat meal).

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics- CL/F Part 1	Up to 96 hours after dosing	Apparent total plasma clearance
Pharmacokinetics- Cmax Part 1	Up to 96 hours after dosing	Maximum plasma concentration of drug
Pharmacokinetics- Tmax Part 1	Up to 96 hours after dosing	Time to maximum plasma concentration
Pharmacokinetics- Vz/F Part 1	Up to 96 hours after dosing	Apparent volume of distribution
Pharmacokinetics- Ratio of Cmax (Formulation A/Formulation B) Part 2	Up to 96 hours after dosing	Ratio of maximum plasma concentration of drug
Pharmacokinetics- Tmax Part 2	Up to 96 hours after dosing	Time to maximum plasma concentration
Pharmacokinetics- t½ Part 1	Up to 96 hours after dosing	Terminal elimination half-life
Pharmacokinetics- Cmax Part 2	Up to 96 hours after dosing	Maximum plasma concentration of drug
Pharmacokinetics- AUC0-t (Formulation A/Formulation B) Part 2	Up to 96 hours after dosing	Area under the plasma concentration-time curve from time zero to the last observable concentration
Pharmacokinetics- t½ Part 2	Up to 96 hours after dosing	Terminal elimination half-life
Pharmacokinetics- Vz/F Part 2	Up to 96 hours after dosing	Apparent volume of distribution
Pharmacokinetics- AUC0-∞ Part 2	Up to 96 hours after dosing	Area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics- AUC0-t Part 2	Up to 96 hours after dosing	Area under the plasma concentration-time curve from time zero to the last observable concentration
Pharmacokinetics- AUC0-∞Part 1	Up to 96 hours after dosing	Area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics- AUC0-t Part1	Up to 96 hours after dosing	Area under the plasma concentration-time curve from time zero to the last observable concentration
Pharmacokinetics- tlag Part 1	Up to 96 hours after dosing	Lag time between time of administration and start of absorption
Pharmacokinetics- Ratio of AUC0-∞ (Formulation A/Formulation B) Part 2	Up to 96 hours after dosing	Ratio of area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics- CL/F Part 2	Up to 96 hours after dosing	Apparent total plasma clearance
Pharmacokinetics- tlag Part 2	Up to 96 hours after dosing	Lag time between time of administration and start of absorption

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics- Cmax (high-fat meal)	Up to 96 hours after dosing	Maximum plasma concentration of drug
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞ (high-fat meal)	Up to 96 hours after dosing	Ratio of area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics- CL/F (high-fat meal)	Up to 96 hours after dosing	Apparent total plasma clearance
Pharmacokinetics- AUC0-∞(high-fat meal)	Up to 96 hours after dosing	Area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics- t½ (high-fat meal)	Up to 96 hours after dosing	Terminal elimination half-life
Pharmacokinetics- Vz/F (high-fat meal)	Up to 96 hours after dosing	Apparent volume of distribution
Pharmacokinetics- tlag (high-fat meal)	Up to 96 hours after dosing	Lag time between time of administration and start of absorption
Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (low-fat meal)	Up to 96 hours after dosing	Ratio of maximum plasma concentration of drug
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (low-fat meal)	Up to 96 hours after dosing	Ratio of area under the plasma concentration-time curve from time zero to the last observable concentration
Pharmacokinetics- AUC0-24 (high-fat meal)	Up to 96 hours after dosing	Area under the plasma concentration-time curve from time zero to 24 hours post dose
Pharmacokinetics- AUC0-∞(low-fat meal)	Up to 96 hours after dosing	Area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics- t½ (low-fat meal)	Up to 96 hours after dosing	Terminal elimination half-life
Pharmacokinetics- Vz/F (low-fat meal)	Up to 96 hours after dosing	Apparent volume of distribution
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (high-fat meal)	Up to 96 hours after dosing	Ratio of area under the plasma concentration-time curve from time zero to the last observable concentration
Pharmacokinetics- Tmax (high-fat meal)	Up to 96 hours after dosing	Time to maximum plasma concentration
Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞(low-fat meal)	Up to 96 hours after dosing	Ratio of area under the plasma concentration-time curve from time zero to infinity
Pharmacokinetics- AUC0-t (low-fat meal)	Up to 96 hours after dosing	Area under the plasma concentration-time curve from time zero to the last observable concentration
Pharmacokinetics- Tmax (low-fat meal)	Up to 96 hours after dosing	Time to maximum plasma concentration
Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (high-fat meal)	Up to 96 hours after dosing	Ratio of maximum plasma concentration of drug
Pharmacokinetics- AUC0-t (high-fat meal)	Up to 96 hours after dosing	Area under the plasma concentration-time curve from time zero to the last observable concentration
Pharmacokinetics- Cmax (low-fat meal)	Up to 96 hours after dosing	Maximum plasma concentration of drug
Pharmacokinetics- CL/F (low-fat meal)	Up to 96 hours after dosing	Apparent total plasma clearance
Pharmacokinetics- tlag (low-fat meal)	Up to 96 hours after dosing	Lag time between time of administration and start of absorption
Incidence of Adverse Events (AEs)	From enrollment until at least 28 days after completion of study treatment	An AE is any noxious, unintended, or untoward medical occurrence that may appear or worsen in a participant during the course of a study. It may be a new intercurrent illness, a worsening concomitant illness, an injury, or any concomitant impairment of the participant's health, including laboratory test values, regardless of etiology. Any worsening (ie, any clinically significant adverse change in the frequency or intensity of a preexisting condition) should be considered an AE.

Trial Locations

Locations (1)

PPD Phase 1 Clinic; 🇺🇸 Austin, Texas, United States