Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-55308942 High Dose · 1 trial · 1 indication
Cmax of probe substrates in cocktail containing selective probes of CYP enzymes (CYP3A, CYP2D6 and CYP2C19) will be determined.
AUC(0-last) of probe substrates in cocktail containing selective probes of CYP enzymes (CYP3A, CYP2D6 and CYP2C19) will be determined.
AUC (0-infinity) of probe substrates in cocktail containing selective probes of CYP enzymes (CYP3A, CYP2D6 and CYP2C19) will be determined.
Cmax is the maximum observed analyte concentration.
AUC(0-last) is defined as the area under the analyte concentration-time curve from time 0 to time of the last quantifiable concentration.
AUC (0-infinity) is the area under the analyte concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the analyte concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant.
| Arm | Type | Description |
|---|---|---|
| Part 1: JNJ-55308942 + Drug Cocktail | EXPERIMENTAL | Participants will receive a single dose of drug cocktail on Day 1 followed by JNJ-55308942 high dose once daily from Day 3 to Day 14 and a single dose of drug cocktail on Day 12. |
| Part 2: JNJ-55308942 + Levonorgestrel/Ethinyl Estradiol | EXPERIMENTAL | Participants will receive a single dose of levonorgestrel/ethinyl estradiol alone on Day 1 followed by JNJ-55308942 high dose once daily on Days 5 to 18 and a single dose of levonorgestrel/ethinyl estradiol on Day 14. |
| Part 3: JNJ-55308942 + Drug Cocktail | EXPERIMENTAL | Participants will receive a single dose of drug cocktail alone on Day 1 followed by JNJ-55308942 low dose once daily on Days 3 to Day 14 and a single dose drug cocktail on Day 12. |
| Name | Type | Description |
|---|---|---|
| JNJ-55308942 High Dose | DRUG | Participants will receive high dose of JNJ-55308942 orally once daily. |
| JNJ-55308942 Low Dose | DRUG | Participants will receive low dose of JNJ-55308942 orally once daily. |
| Levonorgestrel/Ethinyl Estradiol Fixed Dose combination (FDC) | DRUG | Participants will receive 0.150 milligram (mg) levonorgestrel and 0.030 mg ethinyl estradiol FDC tablet orally. |
| Drug Cocktail:Midazolam (2mg)/Omeprazole (20mg)/Dextromethorphan (30mg) | DRUG | Participants will receive single dose of drug cocktail consisting of midazolam (2 mg), dextromethorphan (30mg) and omeprazole (20 mg) orally. |
Inclusion Criteria: * A body mass index (BMI) between 18.0 and 30.0 kilogram per meter square (kg/m\^2), inclusive (BMI = weight/height\^2) * Healthy on the basis of physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening and first admission (D...
JNJ-55308942 High Dose is an investigational small molecule being studied in healthy participants. It is being evaluated in a Phase 1 clinical trial to assess its effects on cytochrome P450 substrate activity and on the pharmacokinetics of levonorgestrel/ethinyl estradiol. The drug is not approved and remains in clinical development.
JNJ-55308942 High Dose is being developed by Johnson & Johnson, a company traded on the stock exchange under the ticker JNJ. The drug is currently in Phase 1 clinical development for use in healthy participants.
JNJ-55308942 High Dose is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The drug has received a Fast Track designation from the FDA, which is intended to expedite its development and review.
JNJ-55308942 High Dose is associated with one completed clinical trial, NCT03547024. This Phase 1 study evaluated the effects of multiple doses of the drug on cytochrome P450 substrate activity and the pharmacokinetics of levonorgestrel/ethinyl estradiol in healthy participants in Belgium.
JNJ-55308942 High Dose is a specific dose level of the investigational drug JNJ-55308942. The clinical trial NCT03547024 evaluates multiple doses of JNJ-55308942, with the high dose being a particular arm of the study. The drug is being developed by Johnson & Johnson.