Treatment sequence A - Prostatic Hyperplasia | Phase 1 | GSK plc | BiopharmaWatch

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Treatment sequence A

Phase 1

Prostatic Hyperplasia | Small molecule | Other |GSK plc|Last Updated: Jun 19, 2018

Success Probability

Approval Probability 71%

TA Base Rate26%

Adjusted LOA41%

ML RiskLOW_RISK

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Market & Valuation

rNPV $3.2B

Market Size $9.4B

Revenue Basis $1.6B

Competitors 6

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Trial Design

RandomizedCONTROLLEDBiomarker

Total Trials2

Total Enrollment165

FDA Designations

No designations recorded

Clinical Trials (2)

NCT ID	Title	Phase	Status	Enrollment	Velocity	Design	Start	Completion	Last Updated	Sites	Countries
NCT02184585	Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted States	PHASE1	COMPLETED	84	—	—	Jul 10, 2014	Feb 23, 2015	Jun 19, 2018	1	United States
NCT00537654	A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State	PHASE1	COMPLETED	81	—	—	Oct 18, 2007	Feb 22, 2008	Aug 17, 2017	2	United States

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Study Endpoints

Primary Endpoints

Area under the curve from 0 to the time of the last quantifiable concentration (AUC[0-t]) of tamsulosin in serum

Pre-dose and post dose at 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hours (h).

Relative bioavailability of tamsulosin will be assessed by evaluating AUC (0-t).

Area under the curve from 0 to infinity (AUC[0-infinity]) of tamsulosin in serum

Pre-dose and post dose at 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 h post dose.

Relative bioavailability of tamsulosin will be assessed by evaluating AUC (0-infinity).

Maximum drug concentration (Cmax) of dutasteride in serum

Pre-dose and post dose at 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 h post dose.

Relative bioavailability of dutasteride will be assessed by evaluating Cmax

AUC(0-t) of dutasteride in serum

Pre-dose and post dose at 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 h post dose.

Relative bioavailability of dutasteride will be assessed by evaluating AUC(0-t)

Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fed state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Area under the curve from time zero to infinity (AUC[0-inf]) of plasma tamsulosin in fed state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Concentration maximum (Cmax) of plasma tamsulosin in fed state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma dutasteride in fed state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Area under the curve (AUC) from time zero to 72 hours (AUC[0-72]) of plasma dutasteride in fed state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Concentration maximum (Cmax) of plasma dutasteride in fed state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fasted state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Area under the curve from time zero to infinity (AUC[0-inf]) of plasma tamsulosin in fasted state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Concentration maximum (Cmax) of plasma tamsulosin in fasted state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma dutasteride in fasted state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Area under the curve (AUC) from time zero to 72 hours (AUC[0-72]) of plasma dutasteride in fasted state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Concentration maximum (Cmax) of plasma dutasteride in fasted state

Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs

Plasma samples will be collected at indicated time points

Secondary Endpoints

Time to reach maximum serum concentration (tmax) of tamsulosin and dutasteride in serum

Pre-dose and post dose at 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 h post dose

Terminal half-life (t½) of tamsulosin in serum (as data permit).

Pre-dose and post dose at 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 h post dose

Safety and tolerability as assessed by Vital signs (blood pressure and pulse rate [PR])

Up to Day 110

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Study Design & Arms

AllocationRANDOMIZED

MaskingNONE

ModelCROSSOVER

PurposeOTHER

Treatment Arms

Arm	Type	Description
Cohort 1: Fasted state	EXPERIMENTAL	Treatment will be administered orally to 42 subjects in the fasted state. Subjects will be required to fast overnight (minimum 10 hours) and for a minimum of 4 hours after each dose. Subjects will participate in 3 treatment periods and assigned to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA) in accordance with the randomization schedule generated by Clinical Statistics. The three treatment periods will be separated by a minimum washout period of 28 days
Cohort 2 : Fed state	EXPERIMENTAL	Treatment will be administered orally to 42 subjects in the fed state (high fat breakfast). Dosing will take place within 30 minutes of the start of the meal. Subjects will participate in 3 treatment periods and assigned to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA) in accordance with the randomization schedule generated by Clinical Statistics. The three treatment periods will be separated by a minimum washout period of 28 days
Fasted state	EXPERIMENTAL	Subjects will be required to fast overnight. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days
Fed state	EXPERIMENTAL	Subjects will be served high fat breakfast 30 minutes prior to dosing. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days

Interventions

Name	Type	Description
Treatment sequence A	DRUG	FDC 1 - Fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg). Each capsule will contain dutasteride (0.5 mg) (CJ) and tamsulosin pellets (0.2 mg) version 1.
Treatment sequence B	DRUG	FDC 2 - Fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg). Each capsule will contain dutasteride (0.5 mg) (CL) and tamsulosin pellets (0.2 mg) version 2.
Treatment sequence C	DRUG	Co-administration of dutasteride 0.5 mg capsule (Oblong, size 6, dull yellow capsules: Commercially available) and tamsulosin hydrochloride 0.2 mg tablet (White, round standard convex tablet: Commercially available).
Treatment sequence D	DRUG	Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state

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Eligibility Criteria

Age Range18 Years — 65 Years

SexMALE

Healthy VolunteersYes

Study Sites1

Inclusion Criteria: * Males aged between 18 and 65 years of age inclusive, at the time of signing the informed consent. * Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac mon...

Countries:United States

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Competitive Landscape -Benign Prostatic Hyperplasia 6 trials

Company	Ticker	Trials	Lead Phase	Drugs
Boston Scientific Corporation	BSX	2	—	Undisclosed
PROCEPT BioRobotics Corp.	PRCT	2	NA	Undisclosed
EDAP TMS SA Sponsored ADR	EDAP	1	NA	Undisclosed
Profound Medical Corp	PROF	1	—	Undisclosed

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