Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Tasocitinib plus Ketoconazole · 3 trials · 1 indication
| Arm | Type | Description |
|---|---|---|
| Tasocitinib (CP-690,550) plus Ketoconazole | EXPERIMENTAL | - |
| Tasocitinib (CP-690,550) plus Rifampin | EXPERIMENTAL | - |
| Treatment A: Tasocitinib 10 mg oral tablet | EXPERIMENTAL | - |
| Treatment B: Tasocitinib 10 mg IV Infusion | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Tasocitinib (CP-690,55) plus Ketoconazole | DRUG | Period 1, Day 1: tasocitinib (CP-690,550) as a single oral 10 mg dose given as two 5 mg tablets Period 2, Days 1-2: ketoconazole as a daily single oral 400 mg (dose given as two 200 mg tablets Period 2, Day 3: ketoconazole as a single oral 400 mg dose given as two 200 mg tablets PLUS tasocitinib (CP-690,550) as a single oral 10 mg oral dose given as two 5 mg tablets Period 2, Day 4: No treatment (discharge) |
| Tasocitinib (CP-690,550) plus Rifampin | DRUG | Period 1, Day 1: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 1-7: Rifampin 600 mg (single oral dose) q24h Period 2, Day 8: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 9: No treatment (discharge) |
| Tasocitinib 10 mg oral tablet | DRUG | Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet |
| Tasocitinib 10 mg IV Infusion | DRUG | Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion |
Inclusion Criteria: * Healthy male and/or female (non-childbearing potential) subjects between the ages of 18 and 55 years Exclusion Criteria: * Clinically significant disease * Recent history of serious infection
Tasocitinib plus Ketoconazole is an investigational combination studied in healthy volunteers and in patients with rheumatoid arthritis. Tasocitinib, also known as CP-690,550, is a small molecule developed by Pfizer. The combination was evaluated in Phase 1 and Phase 2 clinical trials to assess drug absorption and potential interactions.
Tasocitinib plus Ketoconazole was studied for use in healthy volunteers to evaluate pharmacokinetic interactions and in patients with early rheumatoid arthritis to assess joint structure changes via MRI. The combination is investigational and not approved for any indication.
Tasocitinib plus Ketoconazole is developed by Pfizer, Inc., traded on the New York Stock Exchange under the ticker PFE. Pfizer conducted clinical trials of this combination in healthy subjects and in patients with rheumatoid arthritis.
Tasocitinib plus Ketoconazole has completed Phase 1 and Phase 2 clinical trials. The Phase 1 trials evaluated drug absorption and the effect of ketoconazole on tasocitinib pharmacokinetics in healthy volunteers. The Phase 2 trial assessed MRI-measured joint structure in early rheumatoid arthritis. It remains investigational.
Tasocitinib plus Ketoconazole has three completed trials: NCT01143805, a Phase 1 study of CP-690,550 tablet absorption in healthy subjects in Singapore; NCT01164579, a Phase 2 MRI study in early rheumatoid arthritis across multiple countries; and NCT01202240, a Phase 1 study of ketoconazole's effect on tasocitinib pharmacokinetics in healthy volunteers in Belgium.
Yes, Tasocitinib is also known as CP-690,550. Clinical trial records refer to the drug as CP-690,550, and the combination with ketoconazole is sometimes called Tasocitinib plus Ketoconazole. This naming appears in Pfizer's pharmacokinetic and efficacy studies.