Relative Bioavailability and PPI Effects of CC-92480 Test and Reference Formulations in Healthy Subjects

Healthy Volunteer Clinical Trial

Official title:

A Phase 1, Open-label Study to Assess the Single Dose Pharmacokinetics and Relative Bioavailability of a Test Capsule Formulation of CC-92480 Compared to a Reference CC 92480 Capsule Formulation and the Effect of a Proton Pump Inhibitor on the Pharmacokinetics of CC 92480 From Test and Reference Formulations in Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04211545
• Other study ID #: CC-92480-CP-002
• Secondary ID: U1111-1242-7394
• Status: Completed
• Phase: Phase 1
• Start date: October 21, 2019
• Est. completion date: December 26, 2019

Study information

• Verified date: May 2020
• Source: Celgene
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 26, 2019
• Est. primary completion date: December 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

Subjects must satisfy the following criteria to be enrolled in the study (partial):

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

2. 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.

3. 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.

4. For males:

1. 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.

2. 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.

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

6. 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:

1. 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.

2. 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).

3. Use of tobacco - or nicotine-containing products within 3 months prior to Day -1 (Period 1 for Part 2).

4. Vaccination within 30 days of first dose administration or plans to receive vaccination within 30 days after dosing.

5. Subjects with active hepatitis and HIV

6. Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.

7. Use of CYP3A inducers and inhibitors (including St. John's Wort) within 30 days of the first dose administration.

8. 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.

Related Conditions & MeSH terms

• Healthy Volunteer

Intervention

Drug:
• Rabeprazole
Rabeprazole
• CC-92480
CC-92480

Locations

Country	Name	City	State
United States	PPD Phase 1 Clinic	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics - AUC0-8 (Reference Formulation)	Area under the plasma concentration-time curve from time zero to infinity	Up to 5 days
Primary	Pharmacokinetics - AUC0-8 (Test Formulation)	Area under the plasma concentration-time curve from time zero to the last observable concentration at time t	Up to 5 days
Secondary	Pharmacokinetics -Cmax (Reference Formulation)	Maximum plasma concentration	Day 1
Secondary	Pharmacokinetics - Cmax (Test Formulation)	Maximum plasma concentration	Day 1
Secondary	Pharmacokinetics - AUC0-t (Reference Formulation)	Area under the plasma concentration-time curve from time zero to the last observable concentration at time t	Up to 5 days
Secondary	Pharmacokinetics - AUC0-t (Test Formulation)	Area under the plasma concentration-time curve from time zero to the last observable concentration at time t	Up to 5 days
Secondary	Pharmacokinetics -Tmax (Reference Formulation)	Time to peak (maximum) plasma concentration	Day 1
Secondary	Pharmacokinetics -Tmax (Test Formulation)	Time to peak (maximum)plasma concentration	Day 1
Secondary	Pharmacokinetics - CL/F (Reference Formulation)	Apparent total plasma clearance	Up to 5 days
Secondary	Pharmacokinetics - CL/F (Test Formulation)	Apparent total plasma clearance	Up to 5 days
Secondary	Pharmacokinetics - Vz/F (Reference Formulation)	Apparent volume of distribution	Up to 5 days
Secondary	Pharmacokinetics - Vz/F (Test Formulation)	Apparent volume of distribution	Up to 5 days
Secondary	Pharmacokinetics - t1/2 (Reference Formulation)	Terminal elimination half-life	Up to 5 days
Secondary	Pharmacokinetics - t1/2 (Test Formulation)	Terminal elimination half-life	Up to 5 days
Secondary	Adverse Events (AEs)	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.	From enrollment until at least 28 days after completion of study treatment