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Prostatic HyperplasiaPhase 1NCT02184585

Comparative Bioavailability of Two Fixed Dose Combination (FDC) Formulations of Dutasteride and Tamsulosin Hydrochloride Relative to Co-administration of Dutasteride With Tamsulosin Hydrochloride in Healthy Male Subjects Under Fed and Fasted States

A Phase 1 study testing Treatment sequence A, Treatment sequence B and Treatment sequence C in people with Prostatic Hyperplasia, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study will be an open-label, randomized, single dose, three way crossover study in healthy male subjects. The aim of the study is to evaluate the pharmacokinetic parameters of two formulations of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram [mg]/0.2 mg)… Read more about this study

Who is it for?
Ages 18 to 65 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
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteUnited States
Study dates
10 Jul 2014to 23 Feb 2015
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 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Males aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
  • Healthy as determined by a responsible and experienced physician, 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 GSK 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 - 32 kg/m^2 (square meter) (inclusive).
  • Male subjects with female partners of child-bearing potential must agree to use a condom. This criterion must be followed from the time of the first dose of study medication until 50 days post-last dose.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
  • Able to swallow and retain oral medication.
  • Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) <2x (Upper limit of normal) ULN; alkaline phosphatase and bilirubin <=1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
  • Based on single or averaged corrected QT (QTc) values of triplicate electrocardiograms (ECGs) obtained over a brief recording period: QT duration corrected for heart rate by Fridericia's formula (QTcF) <450 milliseconds (msec)

Who cannot join

  • Criteria Based Upon Medical Histories
  • 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 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 GlaxoSmithKline (GSK) Medical Monitor, contraindicates their participation.
  • 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 regular alcohol consumption within 6 months of the study defined for US sites as: 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 diabetes or peptic ulcer disease which is uncontrolled by medical management.
Show all 16Show fewer
  • History of breast cancer or clinical breast examination finding suggestive of malignancy. History of 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. Note: 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.
  • Criteria Based Upon Diagnostic Assessments
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening;
  • A positive pre-study drug/alcohol screen.
  • A positive test for Human Immunodeficiency Virus (HIV) antibody. Other Criteria
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
  • 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: 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.
  • Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) 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, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • GSK Investigational Site

    Baltimore, Maryland, 21225

Other trials in United States

About this study

Official title: An Open-label, Randomized, Single Dose, Three-way Crossover Study to Determine the Bioavailability of Two Fixed Dose Combination Capsule Formulations of Dutasteride and Tamsulosin Hydrochloride (0.5mg/0.2mg) Relative to Co-administration of Dutasteride 0.5mg Capsules and Tamsulosin Hydrochloride 0.2mg Tablets in Healthy Male Subjects in the Fed and Fasted States

This study will be an open-label, randomized, single dose, three way crossover study in healthy male subjects. The aim of the study is to evaluate the pharmacokinetic parameters of two formulations of a fixed dose combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram [mg]/0.2 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin hydrochloride 0.2 mg tablets in both the fed and fasted states. Approximately 84 healthy adult male subjects will be enrolled into the study and split into two cohorts (fed and fasted), allowing for approximately 36 subjects to complete each cohort. Subjects from both cohorts will receive single oral doses in 3 treatment periods and be randomized to one of six different treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA) wherein A= FDC1: Dutasteride and tamsulosin HCl (0.5 mg/0.2 mg), B= FDC2: Dutasteride and tamsulosin HCl (0.5 mg/0.2 mg), C= Co-administration of commercial formulations of dutasteride(0.5mg) and tamsulosin HCl (0.2mg). Each treatment period will be separated by a minimum 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 and review of adverse events.

Being tested
Treatment sequence A, Treatment sequence B, Treatment sequence C
Keywords
bioavailability, crossover design, healthy male volunteers, tamsulosin hydrochloride, Dutasteride
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

    FDC 1 - Fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg). Each capsule will contain dutasteride (0.5 mg) (CJ) and tamsulosin pellets (0.2 mg) version 1.

  • Treatment sequence BDrug

    FDC 2 - Fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg). Each capsule will contain dutasteride (0.5 mg) (CL) and tamsulosin pellets (0.2 mg) version 2.

  • Treatment sequence CDrug

    Co-administration of dutasteride 0.5 mg capsule (Oblong, size 6, dull yellow capsules: Commercially available) and tamsulosin hydrochloride 0.2 mg tablet (White, round standard convex tablet: Commercially available).

Study groups in NCT02184585
Study groupRoleWhat they receive
Cohort 1: Fasted stateExperimentalTreatment will be administered orally to 42 subjects in the fasted state. Subjects will be required to fast overnight (minimum 10 hours) and for a minimum of 4 hours after each dose. Subjects will participate in 3 treatment periods and assigned to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA) in accordance with the randomization schedule generated by Clinical Statistics. The three treatment periods will be separated by a minimum washout period of 28 days
Receives: Drug: Treatment sequence A; Drug: Treatment sequence B; Drug: Treatment sequence C
Cohort 2 : Fed stateExperimentalTreatment will be administered orally to 42 subjects in the fed state (high fat breakfast). Dosing will take place within 30 minutes of the start of the meal. Subjects will participate in 3 treatment periods and assigned to one of six treatment sequences (ABC, ACB, BAC, BCA, CAB, CBA) in accordance with the randomization schedule generated by Clinical Statistics. The three treatment periods will be separated by a minimum washout period of 28 days
Receives: Drug: Treatment sequence A; Drug: Treatment sequence B; Drug: Treatment sequence C

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Area under the curve from 0 to the time of the last quantifiable concentration (AUC[0-t]) of tamsulosin in serum

    Relative bioavailability of tamsulosin will be assessed by evaluating AUC (0-t).

    Measured: Pre-dose and post dose at 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hours (h).

  2. Area under the curve from 0 to infinity (AUC[0-infinity]) of tamsulosin in serum

    Relative bioavailability of tamsulosin will be assessed by evaluating AUC (0-infinity).

    Measured: Pre-dose and post dose at 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 h post dose.

  3. Maximum drug concentration (Cmax) of dutasteride in serum

    Relative bioavailability of dutasteride will be assessed by evaluating Cmax

    Measured: Pre-dose and post dose at 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 h post dose.

  4. AUC(0-t) of dutasteride in serum

    Relative bioavailability of dutasteride will be assessed by evaluating AUC(0-t)

    Measured: Pre-dose and post dose at 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 h post dose.

Secondary outcomes (6)

  1. Time to reach maximum serum concentration (tmax) of tamsulosin and dutasteride in serum

    Pharmacokinetics of dutasteride and tamsulosin will be characterised by measuring tmax.

    Measured: Pre-dose and post dose at 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 h post dose

  2. Terminal half-life (t½) of tamsulosin in serum (as data permit).

    Pharmacokinetics of dutasteride and tamsulosin will be characterised by measuring t½

    Measured: Pre-dose and post dose at 15 min, 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 h post dose

  3. Safety and tolerability as assessed by Vital signs (blood pressure and pulse rate [PR])

    Vital sign measurements will be measured in supine position after 5 minutes rest and will include systolic and diastolic blood pressure and pulse rate. Baseline for vital signs will be defined as the mean of the two blood pressure and pulse readings on Day -1.

    Measured: Up to Day 110

  4. Safety and tolerability as assessed by electrocardiogram (ECG) measurements

    Single 12-lead ECGs will be obtained at each time point during the study using an ECG machine that automatically calculates the heart rate and measures PR, QRS, QT, and QT duration corrected for heart rate by Fridericia's formula (QTcF) intervals. Baseline for ECG will be defined as the mean of three measurements on Day -1

    Measured: Up to Day 110

  5. Safety and tolerability as assessed by review of adverse events (AEs)

    AEs will be collected from the start of dosing with Investigational Product and until the follow-up visit

    Measured: Up to Day 110

  6. Safety and tolerability as assessed by clinical laboratory safety data

    Clinical laboratory tests will include hematology, clinical chemistry and urinalysis

    Measured: Up to Day 56

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2014 (estimated)
  2. Study start10 Jul 2014
  3. Primary completion23 Feb 2015
  4. Study completion23 Feb 2015

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02184585
Sponsor's protocol ID
117057
Status last verified
Jun 2018
First submitted
3 Jul 2014
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.

Publications

  • Burns O, Zhu J, Manyak MJ, Ravindranath R, Koosha F, Haque N, Chung S. Relative Bioavailability of Fixed-Dose Combinations of Tamsulosin and Dutasteride: Results From 2 Randomized Trials in Healthy Male Volunteers. Clin Pharmacol Drug Dev. 2018 May;7(4):422-434. doi: 10.1002/cpdd.380. Epub 2017 Aug 11.

    PubMed 28800206

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 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 8 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?

Area under the curve from 0 to the time of the last quantifiable concentration (AUC[0-t]) of tamsulosin in serum (time frame: Pre-dose and post dose at 15 minutes (min), 30 min, 45 min, 1, 1.5, 2, 3, 6, 8, 10, 12, 18, 24, 36, 48 and 72 hours (h).). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02184585, which also lists 1 linked publication.

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.

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