Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

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

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

Study Overview

• Status: Completed
• Conditions: Erectile Dysfunction; Phosphodiesterase 5 Inhibitor
• Intervention / Treatment: Drug: Placebo; Drug: Udenafil

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.

• Study Type: Interventional
• Enrollment (Actual): 83
• Phase: Phase 1

Contacts and Locations

Study Locations

• Mexico
  • Querétaro, Mexico

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Placebo; Placebo tablets; Drug: Udenafil; Udenafil 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: Placebo; Placebo tablets; Drug: Udenafil; Udenafil 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measured Concentration Above the Lower Limit of Quantification	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).	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-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity	Area under the plasma concentration-time curve from time zero extrapolated to infinity.	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
Cmax: Maximum Observed Plasma Concentration	Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.	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
Tmax: Time to Reach the Maximum Plasma Concentration	Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.	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)	Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.	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

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): August 1, 2013
• Study Completion (Actual): August 1, 2013

Study Registration Dates

• First Submitted: October 17, 2013
• First Submitted That Met QC Criteria: October 17, 2013
• First Posted (Estimate): October 22, 2013

Study Record Updates

• Last Update Posted (Estimate): October 22, 2013
• Last Update Submitted That Met QC Criteria: October 17, 2013
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Keywords: Drug therapy
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Erectile Dysfunction; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Phosphodiesterase Inhibitors; Phosphodiesterase 5 Inhibitors; Udenafil
• Other Study ID Numbers: PK-MX031; U1111-1146-1315 (Other Identifier: World Health Organization)