Prostatic HyperplasiaPhase 1NCT01957189
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
A Phase 1 study testing Dutasteride and Tamsulosin in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Dutasteride and Tamsulosin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 25 Oct 2013to 22 Jan 2014
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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:
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- [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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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 for pharmacokinetic analysis will be taken at pre-specified times. Safety will be assessed by measurement of concurrent medication,changes in clinical laboratory values, ECG, vital signs, and collection of adverse events.Approximately 24 healthy adult males will be enrolled such that approximately 18 subjects complete dosing and critical assessments.This will be an open label, single sequence, three-period study. Approximately 24 healthy male volunteers will be enrolled. At the first study period, the subjects will receive 0.5mg of dutasteride (Dut) as a single dose (SD) under fed conditions. Serum sampling will take place pre-dose and over the next 72 hours post dose (Per. A). After a 28-30 days washout, the subjects will be brought in and be given 0.2mg tamsulosin as Harnal D tablet for 7 days with the morning meal. Serum sampling for pharmacokinetics of tamsulosin will take place at day 1, day 2 and day 3 pre-dose and at days 4 for 24 hours (Per. B). On the next day (Day 5), the subjects will be given both 0.2mg tamsulosin Harnal D tablet and 0.5mg of dutasteride. Serum sampling will take place at Day 5 pre-dose and followed for 72 hours (Per. C) for both dutasteride and tamsulosin. Subjects will participate in a follow-up visit approximately 2 weeks after the last dose of study drug.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Dutasteride and Tamsulosin
- Keywords
- pharmacokinetics, Chinese, Avodart, Duodart, dutasteride, tamsulosin, drug-drug interaction,
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dutasteride and TamsulosinDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Dutasteride with/ without Tamsulosin | Experimental | All subjects will be assigned to the same treatment group Receives: Drug: Dutasteride and Tamsulosin |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the pharmacokinetics of dutasteride and tamsulosin when dosed alone and in combination
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.
Measured: 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,
Secondary outcomes (1)
To evaluate the safety and tolerability of dutasteride and tamsulosin when administered alone and in combination.
AEs, SAEs, concurrent medication, changes in clinical laboratory values, ECG, and vital signs assessments.
Measured: 11 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2013 (estimated)
- Study start25 Oct 2013
- Primary completion22 Jan 2014
- Study completion22 Jan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01957189
- Sponsor's protocol ID
- 200254
- Status last verified
- Jun 2018
- First submitted
- 4 Oct 2013
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01957189
- Acronym / sponsor ID
- 200254
- Conditions
- Prostatic Hyperplasia
- Keywords
- pharmacokinetics, Chinese, Avodart, Duodart, dutasteride, tamsulosin, drug-drug interaction,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2013 (actual)
- Primary completion
- 22 Jan 2014 (actual)
- Study completion
- 22 Jan 2014 (actual)
- First posted
- 8 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 for pharmacokinetic analysis will be taken at pre-specified times. Safety will be assessed by measurement of concurrent medication,changes in clinical laboratory values, ECG, vital signs, and collection of adverse events.Approximately 24 healthy adult males will be enrolled such that approximately 18 subjects complete dosing and critical assessments.This will be an open label, single sequence, three-period study. Approximately 24 healthy male volunteers will be enrolled. At the first study period, the subjects will receive 0.5mg of dutasteride (Dut) as a single dose (SD) under fed conditions. Serum sampling will take place pre-dose and over the next 72 hours post dose (Per. A). After a 28-30 days washout, the subjects will be brought in and be given 0.2mg tamsulosin as Harnal D tablet for 7 days with the morning meal. Serum sampling for pharmacokinetics of tamsulosin will take place at day 1, day 2 and day 3 pre-dose and at days 4 for 24 hours (Per. B). On the next day (Day 5), the subjects will be given both 0.2mg tamsulosin Harnal D tablet and 0.5mg of dutasteride. Serum sampling will take place at Day 5 pre-dose and followed for 72 hours (Per. C) for both dutasteride and tamsulosin. Subjects will participate in a follow-up visit approximately 2 weeks after the last dose of study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dutasteride with/ without Tamsulosin | Experimental | Drug: Dutasteride and TamsulosinAll subjects will be assigned to the same treatment group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (23 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dutasteride and Tamsulosin0.5mg 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 | Drug | Dutasteride with/ without Tamsulosin |
Primary outcome
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,
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.
1 secondary outcome
To evaluate the safety and tolerability of dutasteride and tamsulosin when administered alone and in combination.
Time frame: 11 Weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2018.
- Results for study 200254 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dutasteride and Tamsulosin in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2018.