Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

Takeda

Status and phase: Completed; Phase 1

Conditions: Erectile Dysfunction; Phosphodiesterase 5 Inhibitor

Treatments: Drug: Udenafil; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01967264

PK-MX031

U1111-1146-1315 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 83 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

83 participants in 4 patient groups, including a placebo group

Udenafil 150 mg + Udenafil 150 mg

Experimental group

Description:

Udenafil 150 mg, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.

Treatment:

Drug: Udenafil

Udenafil 150 mg + Placebo

Experimental group

Description:

Udenafil 150 mg, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.

Treatment:

Drug: Udenafil

Drug: Placebo

Placebo + Udenafil 150 mg

Experimental group

Description:

Placebo, tablet, orally, once on Day 1, followed by udenafil 150 mg, tablet, orally, once on Day 3.

Treatment:

Drug: Udenafil

Drug: Placebo

Placebo + Placebo

Placebo Comparator group

Description:

Placebo, tablet, orally, once on Day 1, followed by placebo, tablet, orally, once on Day 3.

Treatment:

Drug: Placebo