drugset / Trial / NCT03547024
A Study in Healthy Participants to Evaluate the Effects of Multiple Doses of JNJ-55308942 on Cytochrome P450 Substrate Activity and on the Pharmacokinetics of Levonorgestrel/Ethinyl Estradiol
Non-randomizedParallel-groupOpen-labelOther
Summary
The purpose of this study is to determine the effect of JNJ-55308942: 1) high dose at steady state on the single dose pharmacokinetics of a cocktail containing selective probes of cytochrome P450 (CYP) enzymes (CYP3A, CYP2D6 and CYP2C19) in healthy adult participants (Part 1); 2) high dose at steady state on the single dose pharmacokinetics of a combination oral contraceptive containing levonorgestrel and ethinyl estradiol in healthy female participants (Part 2); and 3) low dose at steady state on the single dose pharmacokinetics of a cocktail containing selective probes of CYP enzymes (CYP3A, CYP2D6 and CYP2C19) in healthy adult participants (Part 3).
Timeline
- Start
- 2018-06-08
- Primary completion
- 2018-08-30
- Completion
- 2018-08-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dextromethorphan | Unknown | 30 mg | Oral |
| Subject | Levonorgestrel/Ethinyl Estradiol | Unknown | — | Oral |
| Subject | Midazolam | Small molecule | 2 mg | Oral |
| Subject | Omeprazole | Other / unclassified | 20 mg | Oral |
| Subject | ZANVIPIXANT | Small molecule | — | Oral |
Indications
No indication recorded.