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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01929330




Registration number
NCT01929330
Ethics application status
Date submitted
22/08/2013
Date registered
27/08/2013
Date last updated
19/06/2018

Titles & IDs
Public title
Bioequivalence Study of Dutasteride Five 0.1 mg and One 0.5 mg Soft Gelatin Capsules in Healthy Male Volunteers
Scientific title
An Evaluation of the Bioequivalence of Five 0.1 mg GI198745/Dutasteride Soft Gelatin Capsules Compared to One 0.5 mg GI198745/Dutasteride Gelatin Capsules in Healthy Male Volunteers
Secondary ID [1] 0 0
117342
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alopecia 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GI198745 0.1 mg
Treatment: Drugs - GI198745 0.5 mg

Experimental: Sequence AB - 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.

Experimental: Sequence BA - 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.


Treatment: Drugs: GI198745 0.1 mg
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.

Treatment: Drugs: GI198745 0.5 mg
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Serum pharmacokinetic (PK) parameters: maximum observed concentration (Cmax) and Area under the concentration-time curve from time zero to last time of quantifiable concentration within a subject (AUC[0-t]) for dutasteride
Timepoint [1] 0 0
From pre-dose up to 72 hrs
Secondary outcome [1] 0 0
Time to Cmax (tmax) for dutasteride as data permit
Timepoint [1] 0 0
From pre-dose up to 72 hrs
Secondary outcome [2] 0 0
Safety and tolerability of all treatments as assessed by vital signs, electrocardiogram (ECG) measurements, review of adverse events (AEs) and clinical laboratory safety data
Timepoint [2] 0 0
From screening till Follow-up visit (10-14 days post-last dose)& 50-54 days post-last dose

Eligibility
Key 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 monitoring. A subject with a clinical abnormality or laboratory parameter(s)
which is/are not specifically listed in the inclusion or exclusion criteria, outside
the reference range for the population being studied may be included only if the
Investigator, in consultation with the GlaxoSmithKline (GSK) Medical Monitor if
required, judges and documents that the finding is unlikely to introduce additional
risk factors and will not interfere with the study procedures.

- Body weight >= 50 kilogram (kg) and body mass index within the range 19 - 32 kg/square
meter (m2) (inclusive).

- Male subjects with female partners of child-bearing potential must agree to use a
condom. This criterion must be followed from the time of the first dose of study
medication until 50 days post last dose.

- Willing and able to give written informed consent, which includes compliance with all
the requirements and restrictions listed in the consent form for the full duration of
the study, and able to understand and follow instructions related to study procedures.

- Able to swallow and retain oral medication.

- Alanine aminotransferase, Aspartate aminotransferase, alkaline phosphatase and
bilirubin <= 2.0 x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is
acceptable if bilirubin is fractionated and direct bilirubin <35%).

- Based on single or averaged corrected QT interval (QTc) values of triplicate ECGs
obtained over a brief recording period: QT duration corrected for heart rate by
Fridericia's formula (QTcF) < 450 milliseconds.
Minimum age
18 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones).

- History of regular alcohol consumption within 6 months of the study defined as:

An average weekly intake of >21 units for males. In Australia one unit (=standard drink) is
equivalent to 10 gram of alcohol: 270 milliliter (mL) of full strength beer (4.8%), 375 mL
of mid strength beer (3.5%), 470 mL of light beer (2.7%), 250mL pre-mix full strength
spirit (5%), 100 mL of wine (13.5%) and 30 mL of spirit (40%).

- History of sensitivity to any of the study medications, or components thereof or a
history of drug, or other allergy that, in the opinion of the investigator or GSK
Medical Monitor, contraindicates their participation.

- History of myocardial infarction, coronary bypass surgery, unstable angina, cardiac
arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident
prior to Screening visit;

- History of diabetes or peptic ulcer disease which is uncontrolled by medical
management.

- History of: Breast cancer or clinical breast examination finding suggestive of
malignancy; Malignancy within the past five years, except for basal cell carcinoma of
the skin. Subjects with a prior malignancy who have had no evidence of disease for at
least the past 5 years are eligible.

- Prior medical history or evidence of prostate cancer (e.g., positive biopsy, or
suspicious ultrasound, or suspicious digital rectal examination [DRE]). Patients with
suspicious ultrasound or DRE who have had a negative biopsy within the preceding 6
months and stable prostate specific antigen (PSA) are eligible for the study.

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

- A positive pre-study drug/alcohol screen.

- A positive test for HIV antibody.

- Creatinine >1.5xULN normal

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

- 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.

- Unable to refrain from the use of prescription or non-prescription drugs, including
vitamins, herbal and dietary supplements (including St John's Wort) 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.

Study design
Purpose of the study
Other
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
23/09/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/01/2014
Sample size
Target
Accrual to date
Final
36
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
The aim of this study is to determine the bioequivalence of 5 x 0.1 milligram (mg) capsules
compared to 1 x 0.5 mg capsule of dutasteride in healthy male subjects. The results of this
study are expected to support registration applications for androgenetic alopecia (AGA) in
Japan and other international markets.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01929330
Trial related presentations / publications
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01929330