Safety and Pharmacokinetic Profile of Udenafil in Healthy Mexican Adults

NCT01967264 | Completed Phase 1

• 2 other identifiers: PK-MX031U1111-1146-1315
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Erectile Dysfunction; Phosphodiesterase 5 Inhibitor

Keywords

Drug therapy

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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-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

• 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

• 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

• 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

Study Arms (4)

Udenafil 150 mg + Udenafil 150 mg

EXPERIMENTAL

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

Drug: Udenafil

Udenafil 150 mg + Placebo

EXPERIMENTAL

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

Drug: Udenafil; Drug: Placebo

Placebo + Udenafil 150 mg

EXPERIMENTAL

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

Drug: Udenafil; Drug: Placebo

Placebo + Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Udenafil DRUG

Udenafil tablets

Placebo + Udenafil 150 mg; Udenafil 150 mg + Placebo; Udenafil 150 mg + Udenafil 150 mg

Placebo DRUG

Placebo tablets

Placebo + Placebo; Placebo + Udenafil 150 mg; Udenafil 150 mg + Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Sign a letter of informed consent prior to performing any procedure.
• Male
• Clinically healthy
• Age between 18 and 55 years old.
• Body Mass Index (BMI) between 18.5 and 24.9.
• Capability and disposition to attend clinical intervention period

You may not qualify if:

• 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.
• History of psychiatric diseases.
• History of drug abuse (alcohol, tobacco or any other).
• Chronic consumption of caffeine (coffee, cola, green tea, St. Johns Wort).
• Laboratory tests with clinically significant alterations.
• Intestinal disorders that may modify absorption.
• History of allergy to the drug or related drugs.
• Blood donation within 45 days prior to study initiation.
• Participation in a clinical trial within 2 months prior to study initiation.
• History of orthostatic alterations or presyncope.
• Vegetarian diet or other peculiar dietary habits which would interfere the participant's acceptance to standardized meals.
• Inability to communicate or social vulnerability.

Sponsors & Collaborators

• Takeda: lead

Study Sites (1)

Unknown Facility

Querétaro, Mexico

Location

MeSH Terms

Conditions

Erectile Dysfunction

Interventions

udenafil

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders

Study Officials

• Medical Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2013
• First Posted: October 22, 2013
• Study Start: July 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: October 22, 2013

Record last verified: 2013-10

Locations

ME (1)