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

NCT04211545 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-05-08

No results posted yet for this study

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.

Conditions

  • Healthy Volunteer

Interventions

DRUG

Rabeprazole

Rabeprazole

DRUG

CC-92480

CC-92480

Sponsors & Collaborators

  • Celgene

    lead INDUSTRY

Principal Investigators

  • Leon Carayannopoulos, MD · Celgene

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-21
Primary Completion
2019-12-26
Completion
2019-12-26
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04211545 on ClinicalTrials.gov