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UK-396,082 · 1 trial · 5 indications
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Subjects will be assigned to receive either UK-396,082 or placebo |
| Cohort 2 | EXPERIMENTAL | Subjects will be assigned to receive either UK-396,082 or placebo |
| Cohort 3 | EXPERIMENTAL | Subjects will be assigned to receive either UK-396,082 or placebo |
| Cohort 4 | EXPERIMENTAL | Subjects will be assigned to receive either UK-396,082 or placebo |
| Name | Type | Description |
|---|---|---|
| UK-396,082 | DRUG | 100mg given orally twice daily for 14 days The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose. |
| placebo | DRUG | given orally twice daily for 14 days |
Inclusion Criteria: * Healthy subjects. (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests). Exclusion Criteria: * Evidence ...
UK-396,082 is an investigational small molecule drug developed by Pfizer, Inc. (ticker PFE). It has been studied in a Phase 1 clinical trial in healthy adult volunteers, evaluating safety, toleration, and the time course of blood concentration after multiple oral doses. No therapeutic indication has been disclosed for UK-396,082.
Pfizer, Inc., which trades under the ticker PFE, is the developer of UK-396,082. The company sponsored the Phase 1 study of the compound conducted in Belgium. Pfizer is the sole developer named for this asset.
UK-396,082 is in Phase 1 development. One Phase 1 trial has been completed, and no active trials are ongoing. The study enrolled 48 healthy volunteers and assessed multiple oral doses of UK-396,082 for safety, toleration, and pharmacokinetics. The drug is investigational and has not been approved for any use.
UK-396,082 has been studied in one completed Phase 1 trial, NCT01091532, titled a study in healthy people of multiple doses of UK-396,082 given by mouth to investigate safety, toleration, and the time course of blood concentration. The trial enrolled 48 participants in Belgium, was randomized, double blind, and controlled, and included healthy volunteers aged 18 years and older.
Yes. The Phase 1 trial of UK-396,082, NCT01091532, was a randomized, double blind, controlled study. It enrolled 48 healthy volunteers of all sexes, aged 18 years and older, at sites in Belgium. The study evaluated multiple oral doses of UK-396,082 for safety, toleration, and pharmacokinetics, and it has been completed.
The completed Phase 1 trial NCT01091532 studied multiple oral doses of UK-396,082 in 48 healthy adult volunteers in Belgium. Its objectives covered safety, toleration, and the time course of blood concentration of UK-396,082 and its effects. The study was randomized, double blind, and controlled, and enrolled participants aged 18 years and older.