A Pharmacodynamic Study of Dapoxetine Concomitantly Administered in Participants Taking Terazosin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01366664
First received: June 2, 2011
Last updated: April 8, 2013
Last verified: April 2013
  Purpose

The purpose of this study is to assess the pharmacodynamics (the actions or effects a drug has on the body), pharmacokinetics (blood levels), safety, and tolerability of dapoxetine 60 mg when concomitantly administered in participants taking terazosin.


Condition Intervention Phase
Ejaculation
Drug: Treatment sequence 2
Drug: Treatment sequence 1
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-Controlled, Crossover Study Assessing the Pharmacodynamic Effects of Dapoxetine Concomitantly Administered in Subjects Taking Terazosin

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Difference between standing and supine blood pressure measurements [ Time Frame: Days 1-2 ] [ Designated as safety issue: Yes ]
  • Difference between standing and supine blood pressure measurements [ Time Frame: Days 5-6 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Plasma concentrations of dapoxetine [ Time Frame: Blood samples collected prior to and for 24 hours following dapoxetine/placebo administration on Days 1 and 5 of each treatment period and prior to dosing on Days 3 and 4 ] [ Designated as safety issue: No ]
  • Plasma concentrations of dapoxetine metabolite desmethyldapoxetine [ Time Frame: Blood samples collected prior to and for 24 hours following dapoxetine/placebo administration on Days 1 and 5 of each treatment period and prior to dosing on Days 3 and 4 ] [ Designated as safety issue: No ]
  • Number and type of adverse events [ Time Frame: Up to a Maximum of 26 Days ] [ Designated as safety issue: Yes ]
  • Clinical laboratory test values [ Time Frame: Up to a Maximum of 26 Days ] [ Designated as safety issue: Yes ]
  • Physical examination findings [ Time Frame: Up to a Maximum of 26 Days ] [ Designated as safety issue: Yes ]
  • Vital sign measurements [ Time Frame: Up to a Maximum of 26 Days ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: April 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 001
Treatment sequence 1 Treatment Period 1 (stable dose of terazosin [2 to 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2 to 10 mg] + placebo administered orally once daily for 5 days)
Drug: Treatment sequence 1
Treatment Period 1 (stable dose of terazosin [2, 5, or 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2, 5, or 10 mg] + placebo administered orally once daily for 5 days)
Experimental: 002
Treatment sequence 2 Treatment Period 1 (stable dose of terazosin [2 to 10 mg] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2 to 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days)
Drug: Treatment sequence 2
Treatment Period 1 (stable dose of terazosin [2, 5, or 10 mg] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2, 5, or 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days)

Detailed Description:

This is a multiple-center, randomized (participants are assigned to study drug by chance), multiple-dose, double-blind (neither physician nor participant knows the treatment assigned), placebo (inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled, 2-period crossover (participants may receive different interventions sequentially during the trial) study to assess the pharmacodynamics, pharmacokinetics, safety, and tolerability of dapoxetine when concomitantly administered in adult male participants who have been on a stable dose of terazosin or doxazosin for at least 6 weeks. Study drugs used will be terazosin (a drug given for the treatment of hypertension and benign prostatic hyperplasia) and dapoxetine (a new drug being studied for the treatment of premature ejaculation). This study consists of a screening phase followed by a double-blind, placebo-controlled treatment phase consisting of 2 treatment periods. Participants will remain on their prescribed dose of terazosin and participants taking doxazosin will be converted to terazosin using the protocol-defined dose conversion (including assessment of control of urinary symptoms and risk for urinary retention). Participants will be administered concomitant (at the same time) dapoxetine or placebo once daily. Blood samples for pharmacodynamic and pharmacokinetic measurements will be collected at selected times during the study. Safety will be monitored. The total duration of study participation will be approximately 49 days. Participants will remain on their prescribed dose of terazosin (2 to 10 mg taken once daily by mouth) and will be administered daily by mouth concomitant dapoxetine 60 mg or placebo doses during 2 treatment periods (each 7 days in duration conducted in the study center). A period of up to 14 days will separate the treatment periods.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • On a stable regimen of terazosin (2 to 10 mg) or doxazosin (2 to 8 mg) taken daily for at least 6 weeks for the treatment of hypertension or benign prostatic hyperplasia
  • a body mass index between 18 and 35 kg/m², inclusive
  • a body weight of not less than 50 kg
  • supine (laying down) blood pressure measurements between 90 and 150 mmHg, inclusive
  • and, diastolic blood pressure measurements no higher than 95 mmHg.

Exclusion Criteria:

  • History of current clinically significant illness or any other illness that the investigator considers should exclude the study participant or that could interfere with the interpretation of study results
  • symptomatic orthostatic hypotension (a decrease of >=20 mm Hg systolic blood pressure measured after 2 but before 3 minutes after changing from supine (laying down) to standing position)
  • taking a medication that is known to cause orthostatic hypotension, other than terazosin
  • and, taking more than 2 other antihypertensive medications or taking an antihypertensive medication that is excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01366664

Locations
United States, Alabama
Hialeah, Alabama, United States
United States, Arizona
Tempe, Arizona, United States
United States, California
Costa Mesa, California, United States
United States, Florida
Miramar, Florida, United States
United States, Tennessee
Knoxville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Sponsors and Collaborators
Janssen Research & Development, LLC
Investigators
Study Director: Janssen Research & Development, LLC C. Clinical Trial Janssen Research & Development, LLC
  More Information

No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01366664     History of Changes
Other Study ID Numbers: CR018607, R096769PRE1005
Study First Received: June 2, 2011
Last Updated: April 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Janssen Research & Development, LLC:
Premature Ejaculation
Selective Serotonin Reuptake Inhibitor
Dapoxetine
PRILIGY
Terazosin
Pharmacodynamic
Pharmacokinetic

Additional relevant MeSH terms:
Terazosin
Serotonin Uptake Inhibitors
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Neurotransmitter Uptake Inhibitors
Serotonin Agents

ClinicalTrials.gov processed this record on April 17, 2014