Clinical trial NCT04839809: A Study to Assess Safety, Tolerability, and Pharmacokinetics of CC-92480 Formulations in Healthy Adult Participants
Official title: A Phase 1, Two-Part Study to Assess the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of CC-92480; the Relative Bioavailability Among Two Formulations of CC 92480; and Food Effect on the Exposures of Two Formulations of CC 92480 in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Healthy Volunteers
CC-92480
Pharmacokinetics
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2021-04-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetics- Cmax Part 1
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Tmax Part 1
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- AUC0-∞Part 1
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- AUC0-t Part1
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- t½ Part 1
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- CL/F Part 1
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Vz/F Part 1
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- tlag Part 1
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Cmax Part 2
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Ratio of Cmax (Formulation A/Formulation B) Part 2
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- AUC0-∞ Part 2
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Ratio of AUC0-∞ (Formulation A/Formulation B) Part 2
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- AUC0-t Part 2
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- AUC0-t (Formulation A/Formulation B) Part 2
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Tmax Part 2
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- t½ Part 2
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- CL/F Part 2
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Vz/F Part 2
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- tlag Part 2
timeFrame: Up to 96 hours after dosing
Secondary outcomes:
measure: Pharmacokinetics- Cmax (high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- AUC0-∞(high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞ (high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- AUC0-t (high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Tmax (high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- AUC0-24 (high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- t½ (high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- CL/F (high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Vz/F (high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- tlag (high-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Cmax (low-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Ratio (Fed/Fasted) of Cmax (low-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- AUC0-∞(low-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-∞(low-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- AUC0-t (low-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Ratio (Fed/Fasted) of AUC0-t (low-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Tmax (low-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- t½ (low-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- CL/F (low-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- Vz/F (low-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Pharmacokinetics- tlag (low-fat meal)
timeFrame: Up to 96 hours after dosing
measure: Incidence of Adverse Events (AEs)
timeFrame: From enrollment until at least 28 days after completion of study treatment
Other outcomes:
Locations:
city: Austin
country: United States
facility: PPD Phase 1 Clinic
state: Texas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: