Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

Phase 1

Completed

• Conditions: Erectile Dysfunction; Phosphodiesterase 5 Inhibitor
• Interventions: Drug: Udenafil; Drug: Placebo

• Registration Number: NCT01967264
• Lead Sponsor: Takeda

Brief Summary

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

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 Timeline

• Study Start: 2013-07
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-10
• Study First Submitted: 2013-10-17
• Study First Submitted QC: 2013-10-17
• Last Update Submitted: 2013-10-17
• Study First Posted: 2013-10-22
• Last Update Posted: 2013-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 83

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Udenafil 150 mg + Placebo	Placebo	Udenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.
Placebo + Udenafil 150 mg	Placebo	Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.
Placebo + Placebo	Placebo	Placebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.
Udenafil 150 mg + Placebo	Udenafil	Udenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.
Udenafil 150 mg + Udenafil 150 mg	Udenafil	Udenafil 150 mg, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.
Placebo + Udenafil 150 mg	Udenafil	Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.

Primary Outcome Measures

Name	Time	Method
Participants with Adverse Events	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

Name	Time	Method
Cmax: Maximum Observed Plasma Concentration	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	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)	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.
AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 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	Area under the plasma concentration-time curve from time zero extrapolated to infinity.
AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measured Concentration Above the Lower Limit of Quantification	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).