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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT01254071




Registration number
NCT01254071
Ethics application status
Date submitted
2/12/2010
Date registered
6/12/2010
Date last updated
12/06/2017

Titles & IDs
Public title
A Study to Determine the Bioavailability of a Fixed Dose Combination Product of Dutasteride (0.5mg) and Tamsulosin Hydrochloride (0.2mg) Relative to Co-administration of the Individual Components in Healthy Male Subjects of North East Asian and Non-Asian Ancestry.
Scientific title
An Open-label, Randomized, Single Dose, Two-Period Crossover Study to Determine the Bioavailability of a Fixed Dose Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.2mg) Relative to Co-administration of Dutasteride 0.5mg Capsules and Tamsulosin Hydrochloride 0.2mg
Secondary ID [1] 0 0
114694
Universal Trial Number (UTN)
Trial acronym
ARI114694
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostatic Hyperplasia 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Dutasteride (0.5mg); Tamsulosin hydrochloride (0.2mg); fixed dose combination product of duatsteride (0.5mg) and tamsulosin hydrochloride (0.2mg)

Experimental: Fixed dose combination product - Fixed Dose Combination capsule containing dutasteride 0.5mg and tamsulosin 0.2 mg


Treatment: Drugs: Dutasteride (0.5mg); Tamsulosin hydrochloride (0.2mg); fixed dose combination product of duatsteride (0.5mg) and tamsulosin hydrochloride (0.2mg)
In the first dosing session, twenty-two subjects of each cohort will receive the FDC capsule (dutasteride and tamsulosin hydrochloride (0.5mg/0.2mg) and the other 22 will receive commercial capsules of dutasteride 0.5mg and commercial tablets of tamsulosin hydrochloride 0.2mg co-administered. Following a wash-out period of at least 28 days, those subjects who received the FDC capsule in session 1, will be co-administered commercial capsules of dutasteride 0.5mg and commercial tablets of tamsulosin hydrochloride 0.2mg while those who were co-administered commercial capsules of dutasteride 0.5mg and commercial tablets of tamsulosin hydrochloride 0.2mg in session 1 will receive the FDC capsule in the second dosing session.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
1. To investigate the bioavailability of a combination capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.2 mg relative to concomitant dosing of dutasteride 0.5 mg capsules and tamsulosin 0.2 mg tablets in the fed and fasted states.
Timepoint [1] 0 0
PK at pre-dose, at 15,30 and 45 min; 1, 2,3,4,6,8,10,12,16,24,48,and 72 hours.
Secondary outcome [1] 0 0
1. To investigate the effect of food on the bioavailability of a combination capsule formulation of dutasteride 0.5 mg/ tamsulosin HCl 0.2 mg relative to concomitant dosing of dutasteride 0.5 mg capsules and tamsulosin 0.2 mg tablets.
Timepoint [1] 0 0
PK at pre-dose, 15, 30,and 45 mins; 1,2,3,4,6,8,10,12,16,24,48,and 72 hrs.

Eligibility
Key inclusion criteria
- Healthy as determined by a responsible and experienced physician, based on a medical
evaluation including medical history, physical examination, laboratory tests and
cardiac monitoring. A subject with a clinical abnormality or laboratory parameters
outside the reference range for the population being studied may be included only if
the Investigator and the GSK Medical Monitor agree that the finding is unlikely to
introduce additional risk factors and will not interfere with the study procedures.

- Males between 20 and 45 years of age inclusive, at the time of signing the informed
consent form.

- Japanese ancestry defined as being born in Japan, having four ethnic Japanese
grandparents, holding a Japanese passport or identity papers and being able to speak
Japanese, or Korean ancestry defined as being born in Korea, having four ethnic Korean
grandparents, holding a Korean passport or identity papers and being able to speak
Korean, or Chinese ancestry defined as being born in China, Hong Kong, Singapore or
Taiwan, having four ethnic Chinese grandparents, holding a Chinese passport or
identity papers and being able to speak Chinese.

Japanese, Korean and Chinese subjects should also have lived outside their respective
countries for less than 10 years.

- Male subjects with female partners who are either pregnant or suspected of being
pregnant must agree to the use of a condom during sexual activity. This criterion must
be followed from the time of the first dose of study medication until 28 days after
the last dose of study medication.

- BMI : For Caucasians: BMI within the range 18 -30 kg/m2 (inclusive); weight range
55-95 kg (inclusive) For East Asians: BMI within the range 18 -28 kg/m2 (inclusive)
and height 1.55m-1.85m (inclusive).

- Capable of giving written informed consent, which includes compliance with the
requirements and restrictions listed in the consent form.

- Single QTcB < 450 msec.

- AST, ALT, alkaline phosphatase and bilirubin less than or equal to 1.5xULN (isolated
bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin
<35%).
Minimum age
20 Years
Maximum age
45 Years
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Medical Conditions Exclusions:

- Poor metabolizer for CYP2D6 substrates as determined by genotyping of selected CYP2D6
variants at screening.

- History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal
reactions or any other signs and symptoms of orthostasis, which in the opinion of the
investigator could be exacerbated by tamsulosin and result in putting the subject at
risk of injury.

- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).

- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
result within 3 months of screening

- A positive test for HIV antibody.

- Subject is mentally or legally incapacitated.

Medication Exclusions:

- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary
supplements (including St John's Wort, Black Khosh, Dong Quai, Milk Thistle, licorice)
within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives
(whichever is longer) prior to the first dose of study medication, unless in the
opinion of the Investigator and GSK Medical Monitor the medication will not interfere
with the study procedures or compromise subject safety.

- History of sensitivity to tamsulosin hydrochloride or durasteride, components thereof
or drugs of this class or a history of drug or other allergy that, in the opinion of
the investigator or GSK Medical Monitor, contraindicates their participation.

- History of sensitivity to heparin or heparin-induced thrombocytopenia

- The subject has participated in a clinical trial and has received an investigational
product within the following time period prior to the first dosing day in the current
study: 30 days, 5 half-lives or twice the duration of the biological effect of the
investigational product (whichever is longer).

- Exposure to more than four new chemical entities within 12 months prior to the first
dosing day.

Lifestyle Exclusions:

- A positive pre-study drug/alcohol screen. A minimum list of drugs that will be
screened for include amphetamines, barbiturates, cocaine, opiates, cannabinoids and
benzodiazepines.

- History of regular alcohol consumption within 6 months of the screening visit defined
by the following Australian guidelines:

Males: An average weekly intake greater than 21 units or an average daily intake greater
than 3 units. One unit is equivalent to 270 mL of full strength beer, 470 mL of light beer,
30 mL of spirits and 100 mL of wine.

Subjects must be able and willing to abstain from beverages and foods containing alcohol 24
hours prior to and during the dosing day.

- Consumption of red wine, grapefruit juice, grapefruit and related hybrids, jufen
grapes from 7 days prior to the first dose of study medication.

- Where participation in the study would result in donation of blood or blood products
in excess of 500 mL within a 56 day period.

- Unwillingness or inability to follow the procedures outlined in the protocol.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick
Recruitment postcode(s) [1] 0 0
2031 - Randwick

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will be an open-label, randomized, single dose, two-period crossover study to
determine the bioavailability of a fixed dose combination capsule formulation of dutasteride
and tamsulosin hydrochloride (0.5mg/0.2mg) relative to co-administration of dutasteride 0.5mg
capsules and tamsulosin hydrochloride 0.2mg tablets in healthy male subjects of North East
Asian and non-Asian ancestry. Subjects will receive single oral doses of a combination
capsule formulation of dutasteride 0.5 mg/ tamsulosin 0.2 mg in a fed or fasted state or
concomitant dosing of dutasteride 0.5 mg and the Japan-sourced Harnal-D 0.2 mg in a fed or
fasted state. Each dose of study medication will be separated by a 28-day washout period.
Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing.
Safety will be assessed by measurement of blood pressure, heart rate, safety laboratory data,
and review of adverse events. The study will enrol 88 healthy male subjects to ensure that 80
complete the study. At least twenty percent of the study population will be of Japanese
ancestry, approximately 20% will be of Chinese ancestry and approximately 20% of Korean
ancestry while the remainder of the population will be of non-Asian ancestry.
Trial website
https://clinicaltrials.gov/show/NCT01254071
Trial related presentations / publications
Flomax (Tamsulosin hydrochloride) Product Information for the USA, 2009
GlaxoSmithKline Document Number ZM2007/00022/00. ARI109882. An Open-Label, Randomized, Single Dose, Three-Period Crossover Study to Determine the Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART 0.5mg and Flomax 0.4mg Commercial Capsules in Healthy Male Subjects, August 2007
GlaxoSmithKline studyARI40005: A randomised, double-blind, parallel group study to investigate the efficacy and safety of treatment with Dutasteride (0.5mg) and Tamsulosin (0.4mg), administered once daily for 4 years, alone and in combination, on the improvement of symptoms and clinical outcome in men with moderate to severe symptomatic benign prostatic hyperplasia; [GlaxoSmithKline Document Number HM2002/00171/01].
Harnal capsule (Tamsulosin hydrochloride), 0.4mg Product Information for Australia, 2009b.
Harnal D (Tamsulosin hydrochloride), extended release tablet, 0.2mg Product Information for Hong Kong, 2009a.
Matsushima H, Kamimura H, Soeishi Y, Watanabe T, Higuchi S, Tsunoo M. Pharmacokinetics and plasma protein binding of tamsulosin hydrochloride in rats, dogs, and humans. Drug Metab Dispos. 1998 Mar;26(3):240-5.
McConnell JD. The long term effects of medical therapy on the progression of BPH: Results from the MTOPS Trial (abstract 1042). J. Urology 167 (4):265, 2002.
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications