Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2016-004085-26 | EudraCT Number | ||
| 61803534NAP1001 | Other Identifier | Janssen Research & Development, LLC |
Not provided
Not provided
Not provided
Terminated due to nonclinical findings
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the safety and tolerability and pharmacokinetics of JNJ61803534 in healthy participants after administration of single ascending oral doses of JNJ-61803534 (Part 1) and multiple ascending oral doses of JNJ-61803534, administered for 14 consecutive days (Part 2) as well as the potential of JNJ-61803534 to interact with other drugs (Part 3).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Single Ascending Dose (SAD) | Experimental | Participants will receive single oral doses of JNJ-61803534 or placebo in the fasted or fed state. |
|
| Part 2: Multiple Ascending Dose (MAD) | Experimental | Participants will receive JNJ-61803534 or placebo over a 14-day period. |
|
| Part 3: Drug-drug Interaction (DDI) | Experimental | Participants will receive single oral doses of midazolam on Day 1 and Day 16 and will receive JNJ-61803534 daily from Day 3 through Day 16 for 14 days at a dose based on the data from the SAD and MAD part. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JNJ-61803534 | Drug | Participants will receive JNJ-61803534 tablets orally. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Adverse Events (AEs) as a Measure of Safety: Part 1 | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Approximately up to 12 weeks |
| Percentage of Participants With AEs as a Measure of Safety: Part 2 | An adverse event is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product. | Approximately up to 14 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma Concentration of JNJ-61803534 (Parts 1, 2 and 3) | Plasma concentration assessment will be done to characterize the pharmacokinetics (PK) of of JNJ-61803534. | Pre-dose, up to Day 50 (Part 1), up to Day 60 (Part 2), and up to Day 63 (Part 3) |
| Plasma Concentration of Midazolam (Part 3) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Janssen Research & Development, LLC Clinical Trial | Janssen Research & Development, LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Pharmacology Unit | Merksem | 2170 | Belgium |
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Participants will receive matching placebo. |
|
| Midazolam | Drug | Participants will receive single oral dose of midazolam. |
|
Plasma concentration assessment will be done to characterize the effect of JNJ-61803534 on the PK of midazolam. |
| Pre-dose and up to Day 18 |
| Inhibition of Stimulated IL-17A Production in Diluted Whole Blood (Parts 1 and 2) | The amount of IL-17A secreted during the ex-vivo stimulation will be measured during the dosing period. | Pre-dose, up to Day 22 (Part 1 - SAD) and up to Day 43 (Part 2 - MAD) |
| ID | Term |
|---|---|
| D008874 | Midazolam |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided