PPD Phase 1 Clinic
Austin, Texas, 78744, United States
NCT Number: NCT04211545
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.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Austin, Texas, 78744, United States
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):
Exclusion criteria
The presence of any of the following will exclude a subject from enrollment:
Rabeprazole
CC-92480
Time frame: Up to 5 days
Area under the plasma concentration-time curve from time zero to infinity
Time frame: Up to 5 days
Area under the plasma concentration-time curve from time zero to the last observable concentration at time t
Time frame: Day 1
Maximum plasma concentration
Time frame: Day 1
Maximum plasma concentration
Time frame: Up to 5 days
Area under the plasma concentration-time curve from time zero to the last observable concentration at time t
Time frame: Up to 5 days
Area under the plasma concentration-time curve from time zero to the last observable concentration at time t
Time frame: Day 1
Time to peak (maximum) plasma concentration
Time frame: Day 1
Time to peak (maximum)plasma concentration
Time frame: Up to 5 days
Apparent total plasma clearance
Time frame: Up to 5 days
Apparent total plasma clearance
Time frame: Up to 5 days
Apparent volume of distribution
Time frame: Up to 5 days
Apparent volume of distribution
Time frame: Up to 5 days
Terminal elimination half-life
Time frame: Up to 5 days
Terminal elimination half-life
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.
Celgene
Industry
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
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.
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