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31001074/paroxetine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | 31001074/paroxetine 1 tablet of 31001074 will be administered on Day 1 and Day 13. One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15 |
| Name | Type | Description |
|---|---|---|
| 31001074/paroxetine | DRUG | 1 tablet of 31001074 will be administered on Day 1 and Day 13. One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15 |
Inclusion Criteria: * Have a body mass index (BMI) (weight \[kg\]/height2 \[m\]2) between 18 and 30 kg/m2 (inclusive), and body weight not less than 50 kg * Have a blood pressure after the healthy volunteer is supine \[ie, lying down face up\] for 5 minutes between 90 and 140 mmHg systolic, inclusi...
31001074/paroxetine refers to a clinical study pairing the investigational small molecule 31001074 with paroxetine, an approved antidepressant. The trial was a Phase 1 drug interaction study conducted by Johnson & Johnson in healthy adult volunteers in the United States. It is not a single combined product and no therapeutic indication has been disclosed.
Johnson & Johnson, which trades under the ticker JNJ, is the developer of 31001074. The company sponsored the Phase 1 drug interaction study of 31001074 and paroxetine in healthy volunteers. No partnership or licensing arrangement for this compound has been disclosed.
31001074 is in Phase 1 clinical development. The only recorded trial is a completed Phase 1 drug interaction study of 31001074 and paroxetine in healthy volunteers. The compound is investigational and has not been approved by the FDA for any indication.
One clinical trial of 31001074 has been registered: NCT01159821, titled A Drug Interaction Study of 31001074 and Paroxetine in Healthy Volunteers. It was a completed Phase 1 study that enrolled 14 healthy adult participants of both sexes in the United States. No active trials are currently listed.
NCT01159821 was an uncontrolled, non-randomized, open-label Phase 1 study, meaning participants were not assigned to blinded comparison groups. It enrolled 14 healthy volunteers aged 18 years and older in the United States and evaluated the interaction between 31001074 and paroxetine. The study has been completed.