Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

Erectile Dysfunction Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967264
• Other study ID #: PK-MX031
• Secondary ID: U1111-1146-1315
• Status: Completed
• Phase: Phase 1
• First received: October 17, 2013
• Last updated: October 17, 2013
• Start date: July 2013
• Est. completion date: August 2013

Study information

• Verified date: October 2013
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Federal Commission for Sanitary Risks Protection
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Erectile Dysfunction
• Phosphodiesterase 5 Inhibitor

Intervention

Drug:
• Udenafil
Udenafil tablets
• Placebo
Placebo tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No