Last updated: 11/07/2018 12:23:37
Bioavailability study of Fixed Dose Combination (FDC) Dutasteride and Tamsulosin Hydrochloride (HCl) Relative to one Dutasteride and one Tamsulosin HCl tablet in Healthy Male Subjects
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: An Open-label, Randomized, Single Dose, Two-way Crossover study to Determine the Bioavailability of one Fixed Dose Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5 mg/0.2 mg) Relative to Coadministration of one Dutasteride 0.5 mg capsule and one Tamsulosin Hydrochloride 0.2 mg tablet in Healthy Male Subjects in the Fed and Fasted States
Trial description: The primary objective of this study is to determine the bioavailability of a FDC capsule formulation of dutasteride and tamsulosin hydrochloride (0.5 milligram [mg]/0.2 mg) relative to coadministration of one dutasteride 0.5 mg capsule and one tamsulosin HCl 0.2 mg tablet in healthy male subjects in fed and fasted states. This is an open-label, randomized, single dose, two-way crossover study enrolling healthy male subjects, split into fasted (Cohort 1) and fed (Cohort 2) conditions. In both cohorts, one FDC capsule formulation of dutasteride 0.5 mg/tamsulosin HCl 0.2 mg will be administered in one treatment period and the coadministration of dutasteride and tamsulosin hydrochloride in a different treatment period. Each subject enrolled will be allowed to participate in only one cohort (i.e, will receive treatment under fasted or fed conditions) and will participate in both treatment periods. The two treatment periods will be separated by a minimum washout period of 28 days. The total duration in the study for each subject will be approximately 2.5 months from screening to the final follow-up visit.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Maximum observed serum concentration (Cmax) for dutasteride and tamsulosin
Timeframe: Days 1 to 4 of both treatment periods
Area under the serum concentration-time curve (AUC) zero to time ‘t’ (AUC[0-t]) for tamsulosin and dutasteride; AUC 0 to infinity (AUC 0-inf) will be determined for tamsulosin as data permit
Timeframe: Days 1 to 4 of both treatment periods
Secondary outcomes:
Time of occurrence of Cmax (Tmax) for dutasteride and tamsulosin
Timeframe: Days 1 to 4 of both treatment periods
Terminal phase half-life (t1/2) for tamsulosin
Timeframe: Days 1 to 4 of both treatment periods
Number of participants with adverse events (AE) /serious adverse event (SAE) as a measure of safety and tolerability
Timeframe: From start of study treatment until follow-up contact (up to Week 7)
Composite of vital signs as a measure of safety and tolerability
Timeframe: Screening visit, Day -1, and Day 2 (in both treatment periods) and follow-up visit (up to 2.5 months).
Composite of 12-lead electrocardiogram (ECG) assessment as a safety measure
Timeframe: Screening, Day 1 and Day 2 in both treatment periods and follow-up visit (up to 2.5 months).
Interventions:
Enrollment:
56
Primary completion date:
Not applicable
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Olivia Burns, John Zhu, Michael J Manyak, Ramiya Ravindranath, Fariba Koosha, Nazneen Haque, Sally Chung. Relative bioavailability of fixed-dose combinations of tamsulosin and dutasteride: results from two randomized trials in healthy male volunteers. Clin Pharmacol Drug Devel. 2017
Medical condition
Prostatic Hyperplasia
Product
dutasteride, dutasteride/tamsulosin, tamsulosin
Collaborators
Not applicable
Study date(s)
July 2015 to October 2015
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Male subjects aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
- Alanine aminotransferase (ALT) and bilirubin >1.5xUpper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
Inclusion and exclusion criteria
Inclusion criteria:
- Male subjects aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by the investigator or medically qualified designee 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 Medical Monitor if required agree and document 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 (BMI) within the range 18 to 30 kg per meter square (m^2) (inclusive).
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol.
Exclusion criteria:
- Alanine aminotransferase (ALT) and bilirubin >1.5xUpper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35 percent).
- 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 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.
- History of diabetes or peptic ulcer disease which is uncontrolled by medical management.
- Current or history of: Breast cancer or clinical breast examination finding suggestive of breast 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.
- Based on averaged corrected QT (QTc) values of triplicate ECGs obtained over a brief recording period: QTcF > 450 millisecond (msec).
- Subjects must abstain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements), 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 until completion of the follow-up visit, unless in the opinion of the Investigator and sponsor the medication will not interfere with the Study.
- History of regular alcohol consumption within 6 months of the study defined as: For United States sites: an average weekly intake of >14 drinks for males or >7 drinks for females. One drink is equivalent to 12 gram (g) of alcohol: 12 ounces (360 millilitre [mL]) of beer, 5 ounces (150 mL) of wine or 1.5 ounces (45 mL) of 80 proof distilled spirits.
- 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 Medical Monitor, contraindicates their participation.
- Presence of hepatitis B surface antigen (HBsAg), positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment.
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL over the duration of the study.
- 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: 50 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 swallow and retain oral medication.
Trial location(s)
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21225
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2015-10-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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Additional information
Results for study 201897 can be found on the GSK Clinical Study Register.
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