Prostatic HyperplasiaPhase 1ARI115148NCT01577693
Study to Compare the Bioavailability of Dutasteride Novel Formulation Form to the Soft Gel Capsule Form in Healthy Male Subjects
A Phase 1 study testing dutasteride in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 1 site in United States.
Trial summary
The purpose of this study is to determine the bioavailability of 0.5mg dutasteride novel formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted healthy male subjects. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- dutasteride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2011to 31 Aug 2011
- 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 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy as determined by a responsible and experienced physician.
- Males between 20 and 45 years of age inclusive, at the time of signing the informed consent form.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception.
- Body mass index within the range 18-30 kg/m2 (inclusive); weight range 55-95 kg (inclusive).
- Capable of giving written informed consent.
- Single QTcB < 450 msec.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, and bilirubin less than or equal to 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Who cannot join
- History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal reactions or any other signs and symptoms of orthostasis.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for human immunodeficiency virus (HIV) antibody.
- Subject is mentally or legally incapacitated.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements.
Show all 16Show fewer
- History of sensitivity to dutasteride, components thereof or drugs of this class or a history of drug or other allergy.
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- The subject has participated in a clinical trial for 30 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.
- A positive pre-study drug/alcohol screen.
- History of regular alcohol consumption.
- Consumption of red wine, grapefruit juice, grapefruit and related hybrids, and jufen grapes.
- The subject has donated blood or blood products in excess of 500 mL within a 56 day period.
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months.
- Unwillingness or inability to follow the procedures outlined in the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Single Dose, Randomized, Two-period Crossover Study to Investigate the Bioavailability of a Novel Dosage Form of Dutasteride in Healthy Male Subjects
The purpose of this study is to determine the bioavailability of 0.5mg dutasteride novel formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted healthy male subjects.
Read the detailed description
The purpose of this study is to determine the bioavailability of 0.5mg dutasteride in a novel formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted healthy male subjects. This will be an open-label, single dose, randomized, two-period crossover study in healthy male subjects. Subjects will receive a single oral dose 0.5mg novel dutasteride formulation and a single oral dose 0.5mg dutasteride soft gel capsule in a fasted state. Each dose of the study medication will be separated by a 28-day washout period. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, laboratory data, and review of adverse events. The study will enrol approximately 35 healthy male subjects to ensure that 30 subjects complete the study. The study will be conducted in the USA.
- Conditions
- Prostatic Hyperplasia
- Being tested
- dutasteride
- Keywords
- dutasteride, cross over study, bioavailability
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dutasterideDrug
novel dutasteride
dutasterideDrug
dutasteride soft gel capsule
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg novel dose form (test) | Experimental | 0.5 mg novel dose form (test) Receives: Drug: dutasteride |
| 0.5 mg Soft Gel Capsule | Other | 0.5 mg Soft Gel Capsule (reference) Receives: Drug: dutasteride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bioavailability
To assess the dutasteride relative bioavailability of the of 0.5 mg novel formulation compared with the currently marketed 0.5 mg soft gelatin capsule.
Measured: Change from Day 1 (session 1) compared to Day 29 (session 2), predose, .25, .5, .75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72
Secondary outcomes (1)
Safety
Changes in blood pressure and pulse rates, review of number of subjects with adverse events, and changes in clinical laboratory data.
Measured: Changes from screening to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study start12 May 2011
- Primary completion31 Aug 2011
- Study completion31 Aug 2011
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
- 35 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
- NCT01577693
- Sponsor's protocol ID
- 115148
- Acronym
- ARI115148
- Status last verified
- Jun 2018
- First submitted
- 11 Aug 2011
- 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 Dose, Randomized, Two-period Crossover Study to Investigate the Bioavailability of a Novel Dosage Form of Dutasteride in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01577693
- Acronym / sponsor ID
- ARI115148 / 115148
- Conditions
- Prostatic Hyperplasia
- Keywords
- dutasteride, cross over study, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 12 May 2011 (actual)
- Primary completion
- 31 Aug 2011 (actual)
- Study completion
- 31 Aug 2011 (actual)
- First posted
- 16 Apr 2012 (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.
The purpose of this study is to determine the bioavailability of 0.5mg dutasteride novel formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted healthy male subjects.
Detailed description
The purpose of this study is to determine the bioavailability of 0.5mg dutasteride in a novel formulation compared to the currently marketed 0.5mg dutasteride soft gel capsule in fasted healthy male subjects. This will be an open-label, single dose, randomized, two-period crossover study in healthy male subjects. Subjects will receive a single oral dose 0.5mg novel dutasteride formulation and a single oral dose 0.5mg dutasteride soft gel capsule in a fasted state. Each dose of the study medication will be separated by a 28-day washout period. Blood samples for pharmacokinetic analysis will be taken at regular intervals after dosing. Safety will be assessed by measurement of blood pressure, heart rate, laboratory data, and review of adverse events. The study will enrol approximately 35 healthy male subjects to ensure that 30 subjects complete the study. The study will be conducted in the USA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg novel dose form (test) | Experimental | Drug: dutasteride0.5 mg novel dose form (test) |
| 0.5 mg Soft Gel Capsule | Other | Drug: dutasteride0.5 mg Soft Gel Capsule (reference) |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy as determined by a responsible and experienced physician.
- Males between 20 and 45 years of age inclusive, at the time of signing the informed consent form.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception.
- Body mass index within the range 18-30 kg/m2 (inclusive); weight range 55-95 kg (inclusive).
- Capable of giving written informed consent.
Key exclusion criteria (16 listed)
- History of postural hypotension, dizziness, poor hydration, vertigo, vaso-vagal reactions or any other signs and symptoms of orthostasis.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive test for human immunodeficiency virus (HIV) antibody.
- Subject is mentally or legally incapacitated.
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 |
|---|---|---|
| dutasteridenovel dutasteride | Drug | 0.5 mg novel dose form (test) |
| dutasteridedutasteride soft gel capsule | Drug | 0.5 mg Soft Gel Capsule |
Primary outcome
Bioavailability
Time frame: Change from Day 1 (session 1) compared to Day 29 (session 2), predose, .25, .5, .75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72
To assess the dutasteride relative bioavailability of the of 0.5 mg novel formulation compared with the currently marketed 0.5 mg soft gelatin capsule.
1 secondary outcome
Safety
Time frame: Changes from screening to 3 months
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 115148 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.
Related trials for Prostatic Hyperplasia
Active, not recruitingPhase 1/2
RT-310 Safety and Feasibility BPH Study
BPH (Benign Prostatic Hyperplasia)
RecruitingPhase 2
Surface Electrical Stimulation for Urinary Incontinence in Men Treated for Prostate Cancer
Urinary Urge Incontinence, Stress Urinary Incontinence
Not yet recruiting
Prostatic Artery Embolization Using Histoacryl as a Novel Embolizing Agent for Treatment of BPH
Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms
Recruiting
Evaluation of the Aulea Veloxion™ Disposable Resectoscope System for Operational Efficiency in Surgical Management of Benign Prostatic Hyperplasia (BPH)
BPH (Benign Prostatic Hyperplasia)
Recruiting
Comparing Rezum and Urolift
Benign Prostatic Hyperplasia
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 in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 1 site 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 7 inclusion and 16 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 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?
Bioavailability (time frame: Change from Day 1 (session 1) compared to Day 29 (session 2), predose, .25, .5, .75, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 48, 72). 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.