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Trial record 1 of 1 for:    MX031
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Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01967264
First received: October 17, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose
The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg compared to placebo.

Condition Intervention Phase
Erectile Dysfunction
Phosphodiesterase 5 Inhibitor
Drug: Udenafil
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Official Title: A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety Profile and Pharmacokinetic Parameters of Udenafil 150 mg in Healthy Mexican Subjects.

Further study details as provided by Takeda:

Primary Outcome Measures:
  • Participants with Adverse Events [ Time Frame: 3 Weeks ]
    AEs will be evaluated by monitoring participants vital signs, laboratory tests (blood chemistry, hematology, coagulation and serology tests, urianalysis), electrocardiography (ECG).


Secondary Outcome Measures:
  • AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measured Concentration Above the Lower Limit of Quantification [ Time Frame: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose ]
    AUC(0-last) is a measure of total plasma exposure to the drug from Time 0 to the last measured concentration above the lower limit of quantification (LLOQ).

  • AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity [ Time Frame: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose ]
    Area under the plasma concentration-time curve from time zero extrapolated to infinity.

  • Cmax: Maximum Observed Plasma Concentration [ Time Frame: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose ]
    Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.

  • Tmax: Time to Reach the Maximum Plasma Concentration [ Time Frame: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose ]
    Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.

  • Terminal Phase Elimination Half-life (T1/2) [ Time Frame: Predose and at 0.25, 0.5, 0.75, 1, 1.25, 1.5, 2, 3, 5, 7, 9, 12, 24, 36 and 48 hours post-dose ]
    Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.


Enrollment: 83
Study Start Date: July 2013
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Udenafil 150 mg + Udenafil 150 mg
Udenafil 150 mg, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.
Drug: Udenafil
Udenafil tablets
Experimental: Udenafil 150 mg + Placebo
Udenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.
Drug: Udenafil
Udenafil tablets
Drug: Placebo
Placebo tablets
Experimental: Placebo + Udenafil 150 mg
Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.
Drug: Udenafil
Udenafil tablets
Drug: Placebo
Placebo tablets
Placebo Comparator: Placebo + Placebo
Placebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.
Drug: Placebo
Placebo tablets

Detailed Description:

The drug being tested in this study is called Udenafil. Udenafil is being tested to determine a safe and well-tolerated dose. This study will look at vital signs, laboratory tests and side effects in people who take Udenafil.

The study will enroll approximately 84 patients. Participants will be randomly assigned (by chance) and by blocks to assure balanced groups (i.e. same number of participants) to one of the four treatment schemes—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

  • a) Udenafil-Udenafil
  • b) Udenafil- Placebo
  • c) Placebo-Udenafil
  • d) Placebo-Placebo

All participants will be asked to take one tablet on Day 1 and one tablet on Day 3.

This single-centre trial will be conducted in Mexico. The overall time to participate in this study is up to 7 days. Participants will make 3 visits to the clinic, including 5 days confinement to the clinic, and will be contacted by telephone 15 days after last visit to the clinic for a follow-up assessment.

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Sign a letter of informed consent prior to performing any procedure.
  2. Male
  3. Clinically healthy
  4. Age between 18 and 55 years old.
  5. Body Mass Index (BMI) between 18.5 and 24.9.
  6. Capability and disposition to attend clinical intervention period

Exclusion Criteria:

  1. Current use of any allopathic, over the counter (OTC) (e.g. nutritional supplements) or alternative (e.g. herbal) medication within two weeks prior to trial initiation.
  2. History of psychiatric diseases.
  3. History of drug abuse (alcohol, tobacco or any other).
  4. Chronic consumption of caffeine (coffee, cola, green tea, St. Johns Wort).
  5. Laboratory tests with clinically significant alterations.
  6. Intestinal disorders that may modify absorption.
  7. History of allergy to the drug or related drugs.
  8. Blood donation within 45 days prior to study initiation.
  9. Participation in a clinical trial within 2 months prior to study initiation.
  10. History of orthostatic alterations or presyncope.
  11. Vegetarian diet or other peculiar dietary habits which would interfere the participant's acceptance to standardized meals.
  12. Inability to communicate or social vulnerability.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967264

Locations
Mexico
Querétaro, Mexico
Sponsors and Collaborators
Takeda
Investigators
Study Director: Medical Director Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01967264     History of Changes
Other Study ID Numbers: PK-MX031
U1111-1146-1315 ( Other Identifier: World Health Organization )
Study First Received: October 17, 2013
Last Updated: October 17, 2013

Keywords provided by Takeda:
Drug therapy

Additional relevant MeSH terms:
Erectile Dysfunction
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders
Udenafil
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 25, 2017