Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects
Study Details
Study Description
Brief Summary
This is a Phase 1, open-label, randomized, four-period, crossover study in healthy females of nonchildbearing potential and male subjects - to be conducted at a single center in the United States.
The study will consist of a screening phase, a baseline phase, four treatment periods, and a follow-up phone call. The 4 treatment periods are divided into two pairs (Period 1 and 2 and Period 3 and 4), potentially separated by an intermission during which subjects will be discharged from the research unit: Periods 1 and 2 support relative bioavailability (RBA) estimation, while Periods 3 and 4 support estimation of PPI effects.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Administration of CC-92480 and Rabeprazole Test Formulation CC-92480 and Reference Formulation will be administered orally at 1.6 mg. Rabeprazole will be administered orally at 40 mg. |
Drug: Rabeprazole
Rabeprazole
Drug: CC-92480
CC-92480
|
Outcome Measures
Primary Outcome Measures
- Pharmacokinetics - AUC0-∞ (Reference Formulation) [Up to 5 days]
Area under the plasma concentration-time curve from time zero to infinity
- Pharmacokinetics - AUC0-∞ (Test Formulation) [Up to 5 days]
Area under the plasma concentration-time curve from time zero to the last observable concentration at time t
Secondary Outcome Measures
- Pharmacokinetics -Cmax (Reference Formulation) [Day 1]
Maximum plasma concentration
- Pharmacokinetics - Cmax (Test Formulation) [Day 1]
Maximum plasma concentration
- Pharmacokinetics - AUC0-t (Reference Formulation) [Up to 5 days]
Area under the plasma concentration-time curve from time zero to the last observable concentration at time t
- Pharmacokinetics - AUC0-t (Test Formulation) [Up to 5 days]
Area under the plasma concentration-time curve from time zero to the last observable concentration at time t
- Pharmacokinetics -Tmax (Reference Formulation) [Day 1]
Time to peak (maximum) plasma concentration
- Pharmacokinetics -Tmax (Test Formulation) [Day 1]
Time to peak (maximum)plasma concentration
- Pharmacokinetics - CL/F (Reference Formulation) [Up to 5 days]
Apparent total plasma clearance
- Pharmacokinetics - CL/F (Test Formulation) [Up to 5 days]
Apparent total plasma clearance
- Pharmacokinetics - Vz/F (Reference Formulation) [Up to 5 days]
Apparent volume of distribution
- Pharmacokinetics - Vz/F (Test Formulation) [Up to 5 days]
Apparent volume of distribution
- Pharmacokinetics - t1/2 (Reference Formulation) [Up to 5 days]
Terminal elimination half-life
- Pharmacokinetics - t1/2 (Test Formulation) [Up to 5 days]
Terminal elimination half-life
- 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 subject 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 subject's health, including laboratory test values (as specified by the criteria in Section 10.3), 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
Subjects must satisfy the following criteria to be enrolled in the study (partial):
-
Must understand and voluntarily sign a written informed consent form (ICF) prior to any study-related assessments/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 adult male or female 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 PE.
-
For males:
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Practice true abstinence (which must be reviewed on a monthly basis) or agree to use a condom during sexual contact with a pregnant female or a female of childbearing potential while participating in the study, during dose interruptions and for at least 3 months following investigational product discontinuation, even if he has undergone a successful vasectomy.
-
Agree to use 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) 1 while on study medication, and for at 3 months after the last dose of study medication.
-
Must have a body mass index between 18 and 33 kg/m2 (inclusive) at the time of signing the ICF.
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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 judgement.
Exclusion Criteria:
The presence of any of the following will exclude a subject from enrollment:
-
History of any clinically significant and relevant neurological, GI, renal, hepatic, cardiovascular, psychological, pulmonary, metabolic, endocrine, hematological, allergic disease, drug allergies, or other major disorders as determined by the Investigator.
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Exposure 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).
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Use of tobacco - or nicotine-containing products within 3 months prior to Day -1 (Period 1 for Part 2).
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Vaccination within 30 days of first dose administration or plans to receive vaccination within 30 days after dosing.
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Subjects with active hepatitis and HIV
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Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
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Use of CYP3A inducers and inhibitors (including St. John's Wort) within 30 days of the first dose administration.
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Any surgical or medical conditions possibly affecting drug absorption, distribution, metabolism and excretion (ADME), eg, bariatric procedure. Appendectomy and cholecystectomy are acceptable. Prior procedures of unclear ADME significance should be reviewed with the Sponsor's Medical Monitor.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | PPD Phase 1 Clinic | Austin | Texas | United States | 78744 |
Sponsors and Collaborators
- Celgene
Investigators
- Study Director: Leon Carayannopoulos, MD, Celgene
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CC-92480-CP-002
- U1111-1242-7394