Prostatic HyperplasiaPhase 1NCT00537654
A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
A Phase 1 study testing Treatment sequence A, Treatment sequence B and Treatment sequence C in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 2 sites in United States.
Trial summary
This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram [mg]/0.4 mg) relative to co-administration… 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?
- Treatment sequence A, Treatment sequence B and Treatment sequence C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Oct 2007to 22 Feb 2008
- 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
- Healthy subjects defined as individuals who are free from clinically significant illness or disease as determined by the investigator based on their medical history, physical examination, laboratory studies, ECGs, and other tests.
- Males who are 18 - 45 years of age, inclusive.
- Weight range 55 - 95 kg (inclusive) and body mass index 19 - 30 kg/m2 (inclusive).
- Willing and able to give written informed consent, willing to participate for the full duration of the study, and able to understand and follow instructions related to study procedures
Who cannot join
- Slow metabolizer for CYP2D6 as determined by screening PGx analysis.
- 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.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer, such as St. John's Wort) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
- Chronic hepatitis B and C, as evidence by positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody.
- Positive HIV test at screening.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
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- History of regular alcohol consumption exceeding 14 drinks/week for men (1 drink = 5 ounces of wine or 12 ounces of beer or 1.5 ounces of hard liquor) within 6 months of screening. Subjects must be able and willing to abstain from beverages and foods containing alcohol 24 hours prior to and during the dosing day.
- A positive urine drug or alcohol (Breath test or urine) screen result at screening or check-in..
- The subject has received an investigational drug or participated in any other research trial within 30 days 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.
- Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.
- History or presence of allergy, intolerance, or contraindication to tamsulosin HCl or AVODART or drugs of this class, or a history of drug or other allergy (including true sulfonamide allergy) that, in the opinion of the physician responsible, contraindicates their participation.
- Subjects who have consumed the following foods or drinks within 7 days prior to the first dose of study medication or at any time during the clinical phase of the study: grapefruit juice; red wine; grapefruit or cruciferous vegetables (watercress, broccoli, cabbage, Brussels sprouts).
- QTc ≥ 450 msec at screening.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
GSK Investigational Site
Austin, Texas, 78752
GSK Investigational Site
Evansville, Indiana, 47714
About this study
Official title: An Open-Label, Randomized, Single Dose Three-Period Partial Crossover Study to Determine the Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART™ 0.5mg and Flomax 0.4mg Commercial Capsules in Healthy Male Subjects
This study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram [mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy adult male subjects will be enrolled into the study. Subjects will receive single oral doses in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a minimum 28 day washout period. The total duration of a subject's involvement in this study is approximately 15-18 weeks.
Read the detailed description
An Open-Label, Randomized, Single Dose Three-Period Partial Crossover Study to Determine the Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART 0.5mg and FLOMAX 0.4mg Commercial Capsules in Healthy Male Subjects
- Conditions
- Prostatic Hyperplasia
- Being tested
- Treatment sequence A, Treatment sequence B, Treatment sequence C, Treatment sequence D
- Keywords
- benign prostatic hyperplasia,, AVODART,, FLOMAX
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment sequence ADrug
Commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state
Treatment sequence BDrug
Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state
Treatment sequence CDrug
Commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state
Treatment sequence DDrug
Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state
| Study group | Role | What they receive |
|---|---|---|
| Fasted state | Experimental | Subjects will be required to fast overnight. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days Receives: Drug: Treatment sequence C; Drug: Treatment sequence D |
| Fed state | Experimental | Subjects will be served high fat breakfast 30 minutes prior to dosing. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days Receives: Drug: Treatment sequence A; Drug: Treatment sequence B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fed state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Area under the curve from time zero to infinity (AUC[0-inf]) of plasma tamsulosin in fed state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Concentration maximum (Cmax) of plasma tamsulosin in fed state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma dutasteride in fed state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Area under the curve (AUC) from time zero to 72 hours (AUC[0-72]) of plasma dutasteride in fed state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Concentration maximum (Cmax) of plasma dutasteride in fed state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fasted state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Area under the curve from time zero to infinity (AUC[0-inf]) of plasma tamsulosin in fasted state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Concentration maximum (Cmax) of plasma tamsulosin in fasted state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma dutasteride in fasted state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Area under the curve (AUC) from time zero to 72 hours (AUC[0-72]) of plasma dutasteride in fasted state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Concentration maximum (Cmax) of plasma dutasteride in fasted state
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Secondary outcomes (10)
Concentration minimum (Cmax) of plasma tamsulosin
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Time to maximum observed plasma drug concentration (tmax) of tamsulosin and dutasteride
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Elimination half-life (t1/2) of tamsulosin and dutasteride
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Negative slope of the terminal phase of tamsulosin and dutasteride
Plasma samples will be collected at indicated time points
Measured: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Number of subjects with adverse event (AE) and serious adverse event (SAE).
AE is any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgement will be categorized as SAE.
Measured: Up to 18 weeks
Number of subjects with abnormal clinical laboratory parameters
Blood samples will be collected to analyze aspartate aminotransferase (AST), alkaline Phosphatase (ALP), alanine aminotransferase (ALT), creatinine, blood urea nitrogen, creatine kinase, total bilirubin, direct bilirubin, total protein, albumin, glucose, sodium, potassium, calcium
Measured: Up to 18 weeks
Number of subjects with abnormal hematology laboratory parameters
Blood samples will be collected to analyze White Blood Cells (WBC), neutrophils, basophils, eosionophils, lymphocytes, monocytes, Red Blood Cells (RBC) count, RBC indices, Day -1average red blood cell size (MCV), hemoglobin amount per red blood cell (MCH) hemoglobin, hematocrit, and platelet count
Measured: Up to 18 weeks
Number of subjects with abnormal urinalysis
Urine samples will be collected to analyze specific gravity, pH, glucose, protein, blood and ketones
Measured: Up to 18 weeks
Blood pressure assessment as a measure of safety
Systolic and diastolic blood pressure will be measured in a supine position at pre-dose, Days 2, 3, 4,5,6,7,43 and 85 post-dose
Measured: Up to 18 weeks
Measurement of pulse rate as a measure of safety
Pulse rate will be measured in a supine position at pre-dose, Days 2, 3, 4,5,6,7,43 and 85 post-dose
Measured: Up to 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2007 (estimated)
- Study start18 Oct 2007
- Primary completion22 Feb 2008
- Study completion22 Feb 2008
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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 81 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
- NCT00537654
- Sponsor's protocol ID
- ARI109882
- Status last verified
- Aug 2017
- First submitted
- 28 Sep 2007
- Last updated
- 17 Aug 2017
- 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 17 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized, Single Dose Three-Period Partial Crossover Study to Determine the Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART™ 0.5mg and Flomax 0.4mg Commercial Capsules in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT00537654
- Acronym / sponsor ID
- ARI109882
- Conditions
- Prostatic Hyperplasia
- Keywords
- benign prostatic hyperplasia,, AVODART,, FLOMAX
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 18 Oct 2007 (actual)
- Primary completion
- 22 Feb 2008 (actual)
- Study completion
- 22 Feb 2008 (actual)
- First posted
- 1 Oct 2007 (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 study will be an open-label, randomized, single dose, three way partial crossover study in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram [mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy adult male subjects will be enrolled into the study. Subjects will receive single oral doses in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a minimum 28 day washout period. The total duration of a subject's involvement in this study is approximately 15-18 weeks.
Detailed description
An Open-Label, Randomized, Single Dose Three-Period Partial Crossover Study to Determine the Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART 0.5mg and FLOMAX 0.4mg Commercial Capsules in Healthy Male Subjects
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fasted state | Experimental | Drug: Treatment sequence C, Drug: Treatment sequence DSubjects will be required to fast overnight. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days |
| Fed state | Experimental | Drug: Treatment sequence A, Drug: Treatment sequence BSubjects will be served high fat breakfast 30 minutes prior to dosing. Subjects will participate in 3 treatment periods and assigned to one of 12 treatment sequences ( ABC, ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) in accordance with the randomization schedule. The three treatment periods will be separated by a minimum washout period of 28 days |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy subjects defined as individuals who are free from clinically significant illness or disease as determined by the investigator based on their medical history, physical examination, laboratory studies, ECGs, and other tests.
- Males who are 18 - 45 years of age, inclusive.
- Weight range 55 - 95 kg (inclusive) and body mass index 19 - 30 kg/m2 (inclusive).
- Willing and able to give written informed consent, willing to participate for the full duration of the study, and able to understand and follow instructions related to study procedures
Key exclusion criteria (13 listed)
- Slow metabolizer for CYP2D6 as determined by screening PGx analysis.
- 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.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer, such as St. John's Wort) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
- Chronic hepatitis B and C, as evidence by positive Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody.
- Positive HIV test at screening.
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 |
|---|---|---|
| Treatment sequence ACommercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state | Drug | Fed state |
| Treatment sequence BFixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state | Drug | Fed state |
| Treatment sequence CCommercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state | Drug | Fasted state |
| Treatment sequence DFixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state | Drug | Fasted state |
Primary outcome
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fed state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
Area under the curve from time zero to infinity (AUC[0-inf]) of plasma tamsulosin in fed state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
Concentration maximum (Cmax) of plasma tamsulosin in fed state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma dutasteride in fed state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
Area under the curve (AUC) from time zero to 72 hours (AUC[0-72]) of plasma dutasteride in fed state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
Concentration maximum (Cmax) of plasma dutasteride in fed state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fasted state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
Area under the curve from time zero to infinity (AUC[0-inf]) of plasma tamsulosin in fasted state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
Concentration maximum (Cmax) of plasma tamsulosin in fasted state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma dutasteride in fasted state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
Area under the curve (AUC) from time zero to 72 hours (AUC[0-72]) of plasma dutasteride in fasted state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
Concentration maximum (Cmax) of plasma dutasteride in fasted state
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Plasma samples will be collected at indicated time points
10 secondary outcomes
Concentration minimum (Cmax) of plasma tamsulosin
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Time to maximum observed plasma drug concentration (tmax) of tamsulosin and dutasteride
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Elimination half-life (t1/2) of tamsulosin and dutasteride
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Negative slope of the terminal phase of tamsulosin and dutasteride
Time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs
Number of subjects with adverse event (AE) and serious adverse event (SAE).
Time frame: Up to 18 weeks
Number of subjects with abnormal clinical laboratory parameters
Time frame: Up to 18 weeks
Number of subjects with abnormal hematology laboratory parameters
Time frame: Up to 18 weeks
Number of subjects with abnormal urinalysis
Time frame: Up to 18 weeks
Blood pressure assessment as a measure of safety
Time frame: Up to 18 weeks
Measurement of pulse rate as a measure of safety
Time frame: Up to 18 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 17 Aug 2017.
- 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.
- Results for study ARI109882 can be found on the GSK Clinical Study Register.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
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Treatment sequence A, Treatment sequence B and Treatment sequence C in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 2 sites in United States.
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 4 inclusion and 13 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 17 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Area under the curve (AUC) from time zero to 24 hours (AUC[0-24]) of plasma tamsulosin in fed state (time frame: Pre-dose and post dose at 1,2,3,4,5,6,7,8,10,12,16,24,36,48,72hrs). The study lists 12 primary outcomes in all. 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 17 Aug 2017.