Alopecia
Conditions
Keywords
Bioequivalence, Healthy Male Volunteers, Androgenetic Alopecia, Dutasteride, Safety, Tolerability
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.
Interventions
DRUGGI198745 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.
DRUGGI198745 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.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | From pre-dose up to 72 hrs | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Cmax (tmax) for dutasteride as data permit | From pre-dose up to 72 hrs | 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 |
| Safety and tolerability of all treatments as assessed by vital signs, electrocardiogram (ECG) measurements, review of adverse events (AEs) and clinical laboratory safety data | From screening till Follow-up visit (10-14 days post-last dose)& 50-54 days post-last dose | Vital signs will include pulse rate and blood pressure measurements.12-lead ECGs will be obtained at the planned time point. An AE is any untoward medical occurrence temporally associated with the use of the medicinal product, whether or not considered associated with the product. Clinical laboratory tests will include hematology, clinical chemistry and urinalysis parameters. |
Countries
Australia
Outcome results
None listed