Clinical trial NCT01967264: Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Erectile Dysfunction
Phosphodiesterase 5 Inhibitor
Keywords: Drug therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2013-10-22
Enrollment: 83
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

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.

Eligibility 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.

Primary outcomes:
measure: Participants with Adverse Events
timeFrame: 3 Weeks
Secondary outcomes:
measure: AUC(0-last): Area Under the Plasma Concentration-Time Curve From Time 0 to the Last Measured Concentration Above the Lower Limit of Quantification
timeFrame: 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
measure: AUC(0-inf): Area Under the Plasma Concentration-time Curve from Time 0 to Infinity
timeFrame: 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
measure: Cmax: Maximum Observed Plasma Concentration
timeFrame: 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
measure: Tmax: Time to Reach the Maximum Plasma Concentration
timeFrame: 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
measure: Terminal Phase Elimination Half-life (T1/2)
timeFrame: 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
Other outcomes:
Locations:
city: Querétaro
country: Mexico
Study officials:
affiliation: Takeda
name: Medical Director
role: STUDY_DIRECTOR
References: