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GI198745 · 3 trials · 3 indications
Serum PK samples will be collected pre-dose and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48, and 72 hours post dose for both treatment periods
| Arm | Type | Description |
|---|---|---|
| GI198745 | EXPERIMENTAL | - |
| Sequence AB | EXPERIMENTAL | Subjects will be hospitalized to the clinical unit on the evening of Day -1. All subjects will receive 1 x 0.5mg oral dose of dutasteride (Sequence A), in the morning; Subjects will remain in the clinical unit until completion of all assessments at 24 hours post-dose on Day 2 including collection of the 24 hour post-dose PK sample. Subjects will return to the unit for the remaining PK samples at 36, 48 and 72 hours. The subject will receive or 5 x 0.1mg oral dose of dutasteride (Sequence B) in similar fashion as that of Sequence A. The two treatment sequences will be separated by a minimum washout period of 28 days to ensure that dutasteride is effectively eliminated from the subject between dosing occasions. |
| Sequence BA | EXPERIMENTAL | Subjects will be hospitalized to the clinical unit on the evening of Day -1. All subjects will receive 5 x 0.1mg oral dose of dutasteride (Sequence B) in the morning; Subjects will remain in the clinical unit until completion of all assessments at 24 hours post-dose on Day 2 including collection of the 24 hour post-dose PK sample. Subjects will return to the unit for the remaining PK samples at 36, 48 and 72 hours. The subjects will receive 1 x 0.5mg oral dose of dutasteride (Sequence A) in similar fashion as that of Sequence B, The two treatment sequences will be separated by a minimum washout period of 28 days to ensure that dutasteride is effectively eliminated from the subject between dosing occasions. |
| Arm 1 | OTHER | - |
| Name | Type | Description |
|---|---|---|
| GI198745 0.05mg | DRUG | GI198745 (drug) - benign prostatic hyperplasia |
| GI198745 0.5mg | DRUG | GI198745 (drug) - benign prostatic hyperplasia |
| GI198745 2.5mg | DRUG | GI198745 (drug) - benign prostatic hyperplasia |
| GI198745 0.1 mg | DRUG | It is available as soft gelatin capsule to be administered as 5 X 0.1 mg capsules as single oral dose with approximately 250 mL of water. |
| GI198745 0.5 mg | DRUG | It is available as soft gelatin capsule to be administered as 1 X 0.5 mg capsules as single oral dose with approximately 250 mL of water. |
| GI198745 | DRUG | - |
Inclusion Criteria: * Has been receiving the investigational product for at least 20 weeks in the preceding dose finding study and the investigator or subinvestigator has confirmed the tolerability and has judged as appropriate to participate continuously in further 28 weeks treatment. Exclusion C...
Top 1 of 6 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Medicus Pharma Ltd | MDCX | 1 | PHASE2 | Teverelix DP |
GI198745 is an investigational small molecule developed by GSK plc (ticker GSK) for alopecia and benign prostatic hyperplasia, also called prostatic hyperplasia. It has been studied in Phase 1 and Phase 2 clinical trials. GI198745 is not approved and remains in clinical development.
GI198745 has been studied for alopecia and benign prostatic hyperplasia, including prostatic hyperplasia. Clinical trials have evaluated it in male volunteers, with a Phase 1 bioequivalence study in alopecia and a Phase 2 extension study in benign prostatic hyperplasia. It is investigational and not approved for any use.
GI198745 is developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical trials of GI198745, including a Phase 1 bioequivalence study and a Phase 2 extension study in benign prostatic hyperplasia.
GI198745 has been studied in Phase 1 and Phase 2 clinical trials. The Phase 1 trial was a bioequivalence study in healthy male volunteers, and the Phase 2 trial was an extension study in benign prostatic hyperplasia. GI198745 is investigational and not approved.
GI198745 has been evaluated in completed clinical trials including NCT01929330, a Phase 1 bioequivalence study of dutasteride 0.1 mg and 0.5 mg soft gelatin capsules in healthy male volunteers with alopecia, and NCT00969072, a Phase 2 extension study in benign prostatic hyperplasia. A related Phase 1 tamsulosin formulation study was NCT00609596.