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Also known as Treatment sequence 2
Sequence 1 · 2 trials · 2 indications
| Arm | Type | Description |
|---|---|---|
| 001 | EXPERIMENTAL | Treatment sequence 1 Treatment Period 1 (stable dose of terazosin \[2 to 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2 to 10 mg\] + placebo administered orally once daily for 5 days) |
| 002 | EXPERIMENTAL | Treatment sequence 2 Treatment Period 1 (stable dose of terazosin \[2 to 10 mg\] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2 to 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days) |
| Name | Type | Description |
|---|---|---|
| Treatment sequence 2 | DRUG | Treatment Period 1 (stable dose of terazosin \[2, 5, or 10 mg\] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2, 5, or 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days) |
| Treatment sequence 1 | DRUG | Treatment Period 1 (stable dose of terazosin \[2, 5, or 10 mg\] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin \[2, 5, or 10 mg\] + placebo administered orally once daily for 5 days) |
| Sequence 1 | DRUG | Cycle 1: 2 rifampin 300 mg capsules 1x daily for 5 days followed by 2 rifampin capsules prior to trabectedin 1.3 mg/m2 i.v. on Day 1 followed 28 days later by cycle 2 trabectedin 1.3 mg/m2 i.v. on Day 1. Dexamethasone 20 mg i.v. administered prior to trabectedin in each cycle. |
| Sequence 2 | DRUG | Cycle 1: Trabectedin 1.3 mg/m2 i.v. on Day 1 followed by 2 rifampin 300 mg capsules once daily on Days 24-28 followed by Cycle 2, 2 rifampin capsules prior to trabectedin 1.3 mg/m2 i.v. on Day 1 of Cycle 2. Dexamethasone 20 mg i.v. administered prior to trabectedin in each cycle. |
Inclusion Criteria: * On a stable regimen of terazosin (2 to 10 mg) or doxazosin (2 to 8 mg) taken daily for at least 6 weeks for the treatment of hypertension or benign prostatic hyperplasia * a body mass index between 18 and 35 kg/m², inclusive * a body weight of not less than 50 kg * supine (lay...
Sequence 1 is a small molecule being developed by Johnson & Johnson for oncology and other conditions. It is being studied in patients with advanced malignancies, specifically neoplasm metastases, and in a separate study for ejaculation-related conditions. The drug is currently in Phase 1 clinical development.
The molecular target of Sequence 1 has not been disclosed. It is a small molecule therapeutic being investigated for its effects in oncology and ejaculation-related conditions, but the specific biological target is not publicly available.
Sequence 1 is being developed by Johnson & Johnson, a multinational pharmaceutical company listed on the New York Stock Exchange under the ticker JNJ. The company is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in patients with advanced malignancies and in healthy volunteers.
Sequence 1 is in Phase 1 clinical development. It has completed one Phase 1 trial and is not currently in any active trials. The drug is investigational and has not been approved by the FDA for any indication.
Sequence 1 has been studied in two completed Phase 1 trials. NCT01273480 assessed the effects of rifampin on the pharmacokinetics of trabectedin in patients with advanced malignancies, and NCT01366664 studied dapoxetine with terazosin in male participants. Both trials were conducted in the United States.
No, Sequence 1 is not the same as trabectedin or dapoxetine. The trials listed under Sequence 1 evaluate the potential effects of rifampin on trabectedin and the pharmacodynamics of dapoxetine with terazosin, but Sequence 1 itself is a distinct investigational drug being developed by Johnson & Johnson.