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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001932-23 | EudraCT Number |
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A phase 1, 6-sequence, 3-period, subject- and investigator blinded and sponsor-open, crossover study in healthy volunteers to evaluate the PF-06700841 effect on QTc interval. Each subject randomized will receive placebo, PF-06700841 200 mg and moxifloxacin (open label) in one of the 6 sequences. Moxifloxacin is positive control to demonstrate the study sensitivity and PF-06700841 effect on QTc will be assessed by concentration-QT analysis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Seq 1 | Experimental | PF-06700841-> placebo-> moxifloxacin |
|
| Seq 2 | Experimental | PF-06700841->moxifloxacin->placebo |
|
| Seq 3 | Experimental | Placebo->PF-06700841->moxifloxacin |
|
| Seq 4 | Experimental | Placebo->moxifloxacin->PF-06700841 |
|
| Seq 5 | Experimental | Moxifloxacin->PF-06700841->placebo |
|
| Seq 6 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06700841 | Drug | a single oral dose of 200 mg PF-06700841 |
|
| Measure | Description | Time Frame |
|---|---|---|
| QTc change from baseline following PF-06700841 treatment | QTc change from baseline at geometric mean of maximum concentrations observed after single doses of 200 mg PF-06700841 and maximum concentrations expected at lower doses of 30 and 60 mg. | 0 to 48 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| QTc change from baseline following moxifloxacin treatment | QTc change from baseline at 3 hours (Tmax) after a single dose of 400 mg moxifloxacin administration | 0-48 hours post-dose |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Clinical Research Unit | Brussels | B-1070 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36045513 | Derived | Hughes JH, Qiu R, Banfield C, Dowty ME, Nicholas T. Population Pharmacokinetics of Oral Brepocitinib in Healthy Volunteers and Patients. Clin Pharmacol Drug Dev. 2022 Dec;11(12):1447-1456. doi: 10.1002/cpdd.1163. Epub 2022 Aug 31. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| ID | Term |
|---|---|
| C000630838 | PF-06700841 |
| D000077266 | Moxifloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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Moxifloxacin->placebo->PF-06700841
|
| Placebo | Drug | Placebo matching PF-06700841 |
|
| moxifloxacin | Drug | a single oral dose of 400 mg moxifloxacin |
|
| To obtain contact information for a study center near you, click here. | View source |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |