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Completed

NCT Number: NCT01967264

Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

The purpose of this study is to evaluate the safety and tolerability of Udenafil 150 mg compared to placebo.

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Key information

Conditions

Erectile Dysfunction Genital Diseases Genital Diseases, Male Male Urogenital Diseases Mental Disorders Phosphodiesterase 5 Inhibitor Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Querétaro, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.
  • History of psychiatric diseases.
  • History of drug abuse (alcohol, tobacco or any other).
  • Chronic consumption of caffeine (coffee, cola, green tea, St. Johns Wort).
  • Laboratory tests with clinically significant alterations.
  • Intestinal disorders that may modify absorption.
  • History of allergy to the drug or related drugs.
  • Blood donation within 45 days prior to study initiation.
  • Participation in a clinical trial within 2 months prior to study initiation.
  • History of orthostatic alterations or presyncope.
  • Vegetarian diet or other peculiar dietary habits which would interfere the participant's acceptance to standardized meals.
  • Inability to communicate or social vulnerability.

Treatment and study plan

Udenafil

Drug

Udenafil tablets

Placebo

Drug

Placebo tablets

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

A Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety Profile and Pharmacokinetic Parameters of Udenafil 150 mg in Healthy Mexican Subjects.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2013
Registry last updated
Oct 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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