- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01957189
This Will be an Open-label, Three-period, Fixed-sequence Study to Evaluate the Drug-drug Interaction, Pharmacokinetics and Safety of Dutasteride and Tamsulosin When Administered Alone and In-combination in Chinese Healthy Male Volunteers. The Study Will Last Approximately Eleven Weeks. Blood Samples
An Open Label, Single Sequence, Three Period, Drug-Drug Interaction Study To Examine The Pharmacokinetics Of Dutasteride And Tamsulosin And Their Interactions In Chinese Male Healthy Volunteers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Shanghai, China, 200030
- GSK Investigational Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Ethnic Chinese male subject between the ages of 18 and 45 years old inclusive, at the time of signing the informed consent.
- Ethnic Chinese are defined as being born in China, having four ethnic Chinese grandparents, stay in China for most time and be abroad no more than 10 years.
- Healthy subjects defined as individuals who are free from significant cardiac,pulmonary, gastrointestinal, hepatic, renal, hematological, neurological, endocrinological and psychiatric disease as determined by medical history,physical examination, vital signs, electrocardiogram (ECG) and clinical laboratory test results.
- Body weight >= 50 Kilogram (kg) and BMI within the range 19 - 24 kg/m2(inclusive).
- Serum creatinine < 1.5xULN at screening.
- Based on single or averaged QTc values of triplicate ECGs obtained over a brief recording period:
[QTc] < 450 Milliseconds (msec); or QTc < 480 msec in subjects with Bundle Branch Block.
- Alanine aminotransferase (ALT), alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
- Subjects must be able and willing to stop using of any tobacco or nicotine containing products 24 hours prior to each dose and for the duration of confinement. At the discretion of the Investigator, light smokers (smoking ≤10 cigarettes a day) would be considered for the study inclusion.
- Willing and able of giving written informed consent, which includes compliance with the 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.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods.This criterion must be followed from the time of the first dose of study medication until 50 days after the last dose.
Exclusion Criteria:
- The subject has received an investigational product or participated in any other research trial within 6 months or 5 half-lives, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication or anytime during the study period, or exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Previous use of the following medications or involvement in an investigational drug study of any of these in the previous three months prior to screening:
finasteride, (PROSCAR, PROPECIA) investigational 5 ARIs (i.e., GI198745 and epristeride) phytotherapy (i.e., over the counter plant extracts for BPH and alopecia) anabolic steroids (i.e., oxandrolone, testosterone ester) drugs with anti-androgenic properties (i.e., spironolactone, cimetidine) alpha-1 antagonists (i.e., terazosin, doxazosin, alfuzosin and tamsulosin) antihypertensive agents or diuretics
- Previous donation of blood or blood products in excess of 500 mL within a 90 day prior to the first dose of investigational products and the subject agrees not to donate blood during this study.
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of >21 units for males. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits. Subjects must be able and willing to abstain from beverages and foods containing alcohol 24 hours prior to the first dose of study medication and until collection of the final pharmacokinetic sample during each period.
- Positive test result for Hepatitis B surface antigen (HBsAg), Hepatitis C surface antibody (HCAb), or HIV antibody at Screening.
- Subjects with a positive urinary drug or alcohol screen at screening and at Day -1of study participation.
- Poor metabolizer for CYP2D6 substrates as determined by genotyping of selected CYP2D6 variants at screening.
- Subjects with an acute illness requiring treatment by a physician within 30 days proceeding the screening period of the study, or a significant febrile illness within five days of the first day the subject will receive the study drug.
- Subjects with sensitivity to currently available 5 ARIs (i.e., finasteride).
- Subjects with sensitivity to currently available alpha 1 antagonists (i.e., terazosin doxazosin, alfuzosin and tamsulosin). History or presence of allergy, intolerance, or contraindication to tamsulosin or dutasteride or any of its components, soya or peanuts, or drugs of these therapeutic classes, or a history of drug or other allergy (including true sulfonamide allergy) that, in the opinion of the physician responsible, contraindicates their participation.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal, dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer, such as St. John's Wort, Black Cohosh, Dong Quai, milk thistle, and licorice) or 5 half-lives (whichever is longer) prior to the first dose of study medication and up to 4 days from receiving the last dose of study medication.
- Unable to refrain from the consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pomelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication until collection of the last blood sample for determination of pharmacokinetic parameters.
- Any clinically significant abnormality on the screening ECG or screening laboratory tests.
- 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.
- Prior medical history or evidence of prostate cancer (e.g., positive biopsy, or suspicious ultrasound, or suspicious digital rectal examination (DRE)). Subjects 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. The investigator should make every appropriate effort to exclude the possibility of prostate cancer, including consideration of prostate biopsy in any subject with a known abnormal PSA.
- 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.
- History of any serious and/or unstable pre-existing medical, psychiatric disorder, or other conditions that could interfere with a subject's safety, or interfere with the subject's ability to follow indications or study procedures, or the interpretation of study results or obtaining informed consent or compliance to study procedures in the opinion of the Investigator or GSK Medical Monitor.
- History of myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident prior to Screening visit; or diabetes or peptic ulcer disease which is uncontrolled by medical management.
- Unable to refrain from the use of strong CYP3A4 inhibitors (e.g. ketoconazole) and/or strong CYP2D6 inhibitors (e.g. paroxetine) throughout the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Dutasteride with/ without Tamsulosin
All subjects will be assigned to the same treatment group
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0.5mg dutasteride once a day on Day 1 Period A , and Day 5 Period C,0.2mg Tamsulosin once a day on Day 1 to Day 7 in Period B and Period C
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the pharmacokinetics of dutasteride and tamsulosin when dosed alone and in combination
Time Frame: Pre-dose (within 10 minutes of the dutasteride administration), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose.Pre-dose (within 10 minutes of tamsulosin administration) on Day 1, Day 2 and Day 3 and pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6,
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Serum dutasteride AUC (0-t), Cmax, tmax, following 0.5mg single dose administration with and without tamsulosin 0.2mg q24h.
Serum tamsulosin AUC(0-τ), Cmax, tmax, Cτ and CL/F following 0.2mg q24h administration with and without dutasteride 0.5mg single dose.
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Pre-dose (within 10 minutes of the dutasteride administration), 0.25, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 24, 48 and 72 hours post dose.Pre-dose (within 10 minutes of tamsulosin administration) on Day 1, Day 2 and Day 3 and pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6,
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate the safety and tolerability of dutasteride and tamsulosin when administered alone and in combination.
Time Frame: 11 Weeks
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AEs, SAEs, concurrent medication, changes in clinical laboratory values, ECG, and vital signs assessments.
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11 Weeks
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Prostatic Diseases
- Prostatic Hyperplasia
- Hyperplasia
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Urological Agents
- Enzyme Inhibitors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Steroid Synthesis Inhibitors
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- 5-alpha Reductase Inhibitors
- Tamsulosin
- Dutasteride
Other Study ID Numbers
- 200254
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
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Clinical Study Report
Information identifier: 200254Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 200254Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 200254Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Annotated Case Report Form
Information identifier: 200254Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 200254Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Statistical Analysis Plan
Information identifier: 200254Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 200254Information comments: For additional information about this study please refer to the GSK Clinical Study Register
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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