Clinical Pharmacology Unit
Merksem, 2170, Belgium
NCT Number: NCT04448964
The purpose of this study is to evaluate the pharmacokinetics (PK) and relative bioavailability of a single dose of JNJ-70033093 spray dried dispersion (SDD) tablets compared with JNJ-70033093 SDD granule capsules in healthy participants under fasting conditions in Part 1 and 2 and to assess the effect of food on the bioavailability of a single dose of JNJ-70033093 SDD tablets in Part 1.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Merksem, 2170, Belgium
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
JNJ-70033093 will be administered orally as per assigned treatment sequence.
Other names: BMS-986177
Time frame: Up to 72 hours post dose
Cmax is defined as maximum observed plasma concentration after administration of JNJ-70033093.
Time frame: Up to 72 hours post dose
AUC (0-last) is defined as area under the plasma concentration-time curve from time 0 to time of last quantifiable concentration after administration of JNJ-70033093.
Time frame: Up to 72 hours post dose
AUC (0-inf) is defined as area under the plasma concentration-time curve from time 0 to infinity after administration of JNJ-70033093.
Time frame: Up to 72 hours post dose
Tmax is defined time to reach the maximum observed plasma concentration.
Time frame: Up to 72 hours post dose
Apparent elimination half-life associated with the terminal slope lambda(z) of the semilogarithmic drug concentration-time curve.
Time frame: Up to 2 Months
An AE is any untoward medical occurrence in a clinical study participant administered a investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Time frame: Up to 2 Months
Number of participants with clinically significant changes in vital signs including temperature (axillary), pulse rate, respiratory rate, blood pressure will be reported.
Time frame: Up to 2 Months
Number of participants with abnormalities in ECG will be reported.
Time frame: Up to 2 Months
Number of participants with clinically significant changes in physical examination including height and body weight will be reported.
Janssen Research & Development, LLC
Industry
A Randomized, Open-Label, 3-way Cross-over (Part 1) and 2-way Cross-over (Part 2) Study in Healthy Participants to Evaluate the Relative Bioavailability and the Food Effect of an Oral Tablet Formulation Relative to a Capsule Formulation of JNJ-70033093
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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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