Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

Phase 1CompletedNCT01967264

Takeda83 enrolled

Overview

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

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

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Erectile Dysfunction Phosphodiesterase 5 Inhibitor

Interventions

UdenafilDRUG

Udenafil tablets

PlaceboDRUG

Placebo tablets

Eligibility

Sex: MALEMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Unnamed facility

Querétaro, Mexico

Outcomes

Primary Outcomes

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).

Time frame: 3 Weeks

Secondary Outcomes

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).

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-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.

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

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.

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

Tmax: Time to Reach the Maximum Plasma Concentration

Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax.

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)

Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.

Data from ClinicalTrials.gov

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