Skip to main content
OpenTrials
Completed

NCT Number: NCT04211545

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

PPD Phase 1 Clinic

Austin, Texas, 78744, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.
  • 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.
  • 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).
  • Use of tobacco - or nicotine-containing products within 3 months prior to Day -1 (Period 1 for Part 2).
  • Vaccination within 30 days of first dose administration or plans to receive vaccination within 30 days after dosing.
  • Subjects with active hepatitis and HIV
  • Use of any nonprescribed systemic or topical medication (including vitamin/mineral supplements, and herbal medicines) within 14 days of the first dose administration.
  • Use of CYP3A inducers and inhibitors (including St. John's Wort) within 30 days of the first dose administration.
  • 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.

Treatment and study plan

rabeprazole

Drug

Rabeprazole

CC-92480

Drug

CC-92480

Primary outcomes

  1. Pharmacokinetics - AUC0-∞ (Reference Formulation)

    Time frame: Up to 5 days

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

  2. Pharmacokinetics - AUC0-∞ (Test Formulation)

    Time frame: Up to 5 days

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

Secondary outcomes

  1. Pharmacokinetics -Cmax (Reference Formulation)

    Time frame: Day 1

    Maximum plasma concentration

  2. Pharmacokinetics - Cmax (Test Formulation)

    Time frame: Day 1

    Maximum plasma concentration

  3. Pharmacokinetics - AUC0-t (Reference Formulation)

    Time frame: Up to 5 days

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

  4. Pharmacokinetics - AUC0-t (Test Formulation)

    Time frame: Up to 5 days

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

  5. Pharmacokinetics -Tmax (Reference Formulation)

    Time frame: Day 1

    Time to peak (maximum) plasma concentration

  6. Pharmacokinetics -Tmax (Test Formulation)

    Time frame: Day 1

    Time to peak (maximum)plasma concentration

  7. Pharmacokinetics - CL/F (Reference Formulation)

    Time frame: Up to 5 days

    Apparent total plasma clearance

  8. Pharmacokinetics - CL/F (Test Formulation)

    Time frame: Up to 5 days

    Apparent total plasma clearance

  9. Pharmacokinetics - Vz/F (Reference Formulation)

    Time frame: Up to 5 days

    Apparent volume of distribution

  10. Pharmacokinetics - Vz/F (Test Formulation)

    Time frame: Up to 5 days

    Apparent volume of distribution

  11. Pharmacokinetics - t1/2 (Reference Formulation)

    Time frame: Up to 5 days

    Terminal elimination half-life

  12. Pharmacokinetics - t1/2 (Test Formulation)

    Time frame: Up to 5 days

    Terminal elimination half-life

  13. Adverse Events (AEs)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Celgene

Industry

Registry information

Official study 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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 26, 2019
Registry last updated
May 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.