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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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Boston Scientific Corporation | BSX | 2 | - | Undisclosed |
| PROCEPT BioRobotics Corp. | PRCT | 2 | N/A | Undisclosed |
| EDAP TMS SA Sponsored ADR | EDAP | 1 | N/A | Undisclosed |
| Profound Medical Corp | PROF | 1 | - | Undisclosed |
GI198745 is an investigational small molecule being developed for benign prostatic hyperplasia, prostatic hyperplasia, and alopecia. It is currently in Phase 1 clinical development and is not approved by the FDA.
GI198745 is being developed by GSK plc, which trades under the ticker GSK. The drug is an investigational small molecule in Phase 1 clinical development for benign prostatic hyperplasia, prostatic hyperplasia, and alopecia.
GI198745 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials have been completed for prostatic hyperplasia and alopecia, with one Phase 1 study completed.
GI198745 has been studied in clinical trials including NCT00609596, a Phase 1 study comparing formulations of tamsulosin in prostatic hyperplasia; NCT00969072, a Phase 2 extension study in benign prostatic hyperplasia; and NCT01929330, a Phase 1 bioequivalence study in alopecia.
GI198745 is not the same as dutasteride, but it has been studied in combination with it. A clinical trial, NCT01929330, evaluated the bioequivalence of dutasteride capsules in healthy male volunteers, indicating GI198745 may be studied alongside or compared to dutasteride.