A Pharmacodynamic Study of Dapoxetine Concomitantly Administered in Participants Taking Terazosin
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| ClinicalTrials.gov Identifier: NCT01366664 |
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Recruitment Status :
Completed
First Posted : June 6, 2011
Last Update Posted : October 7, 2014
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Sponsor:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Janssen Research & Development, LLC
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Ejaculation | Drug: Treatment sequence 2 Drug: Treatment sequence 1 | Phase 1 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 24 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, 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 |
| Study Start Date : | April 2011 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | April 2012 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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)
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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) |
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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)
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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) |
Primary Outcome Measures :
- Difference between standing and supine blood pressure measurements [ Time Frame: Days 1-2 ]
- Difference between standing and supine blood pressure measurements [ Time Frame: Days 5-6 ]
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 ]
- 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 ]
- Number and type of adverse events [ Time Frame: Up to a Maximum of 26 Days ]
- Clinical laboratory test values [ Time Frame: Up to a Maximum of 26 Days ]
- Physical examination findings [ Time Frame: Up to a Maximum of 26 Days ]
- Vital sign measurements [ Time Frame: Up to a Maximum of 26 Days ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01366664
Locations
| United States, Alabama | |
| Anniston, 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 |
Additional Information:
| Responsible Party: | Janssen Research & Development, LLC |
| ClinicalTrials.gov Identifier: | NCT01366664 History of Changes |
| Other Study ID Numbers: |
CR018607 R096769PRE1005 ( Other Identifier: Janssen Research & Development, LLC ) |
| First Posted: | June 6, 2011 Key Record Dates |
| Last Update Posted: | October 7, 2014 |
| Last Verified: | October 2014 |
Keywords provided by Janssen Research & Development, LLC:
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Premature Ejaculation Selective Serotonin Reuptake Inhibitor Dapoxetine PRILIGY |
Terazosin Pharmacodynamic Pharmacokinetic |
Additional relevant MeSH terms:
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Serotonin Uptake Inhibitors Terazosin Prazosin Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |
Physiological Effects of Drugs Adrenergic alpha-1 Receptor Antagonists Adrenergic alpha-Antagonists Adrenergic Antagonists Adrenergic Agents Urological Agents Antihypertensive Agents |