A Comparative Pharmacokinetic and Pharmacodynamic Study of Sildenafil in Adult Smokers and Non Smokers

NCT04100759 | Completed Phase 1

• 1 other identifier: SIL-RES-0119
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

Smokers are at higher risk of developing Erectile dysfunction (ED) independent of age and comorbidities. Sildenafil is a cytochrome p3A4 (CYP3A4) substrate used for enhancing the erectile function in males. The study purpose is to determine the effect of smoking on male sexual function based on the international index of erectile function score (IIEF) and investigate the effect of smoking (Cigarettes or marijuana) on the pharmacokinetics and pharmacodynamics of sildenafil.

Conditions

Erectile Dysfunction; Smoking; Pharmacokinetics; Pharmacodynamics

Outcome Measures

Primary Outcomes (2)

• Maximum drug concentration in plasma (Cmax)

  Maximum drug concentration in plasma measured in nano-grams per milliliters (ng/ml)

  up to 3 hours post-dose

• Area under the plasma concentration-time curve from time zero to the last quantifiable concentration post-dose (AUC0→t)

  Area under the plasma concentration-time curve from time 0 to time(t) measured in nano-grams multiplied by hours and divided by milliliters (ng.h/ml)

  up to 24 hours post-dose

Secondary Outcomes (3)

• Time to Maximum drug concentration in plasma (tmax)

  up to 3 hours post-dose

• Elimination half life of drug in plasma ( t½)

  Up to 24 hours post-dose

• Area under the plasma concentration-time curve from time 0 to infinity

  Up to 24 hours post-dose

Study Arms (3)

Non-Smokers

EXPERIMENTAL

Subjects administer one tablet of sildenafil 50 mg

Drug: Sildenafil 50 mg Oral Tablet

Cigarette Smokers

EXPERIMENTAL

Subjects administer one tablet of sildenafil 50mg

Drug: Sildenafil 50 mg Oral Tablet

Cannabis Smokers

EXPERIMENTAL

Subjects administer one tablet of sildenafil 50mg

Drug: Sildenafil 50 mg Oral Tablet

Interventions

Sildenafil 50 mg Oral Tablet DRUG

Sildenafil 50 mg Oral Tablet

Also known as: Viagra 50 mg film coated tablets

Cannabis Smokers; Cigarette Smokers; Non-Smokers

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: subjects are to provide their national IDs to confirm that subjects are male subjects
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male subjects
• Age 18-55 years.
• Ideal weight with ideal body mass index(BMI).
• Non-contributory history and normal physiological examination.
• Laboratory data within normal limits.
• Performance and compliance.
• The subjects should be without known history of alcohol or drug abuse problems
• Subjects who are cigarette smokers
• Subjects who are cannabis smokers
• Subjects who are non-smokers

You may not qualify if:

• A known hypersensitivity to the drug.
• Gastrointestinal diseases.
• Auto immune diseases.
• Renal diseases or dysfunction.
• Cardiovascular disease of any type.
• Pancreatic disease including diabetes.
• Hepatic disease.
• Hematological, osteopathic, or pulmonary disease.
• History of alcoholism or drug abuse.
• Serious Psychological illness.
• Positive HIV.
• Abnormal (out of range) laboratory values.
• Subject who have taken any medication less than two weeks of the trials starting date.
• Subject who have donated blood or who have been in multiple dosing studies requiring a large volume of blood (more than 500 ml) to be drawn within six weeks preceding the start of the trials.

Sponsors & Collaborators

• Ain Shams University: lead
• Drug Research Centre, Cairo, Egypt: collaborator

Study Sites (1)

Drug Research Centre

Cairo, Sheraton Heliopolis, Egypt

Location

MeSH Terms

Conditions

Erectile Dysfunction; Smoking

Interventions

Sildenafil Citrate; Tablets

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Dosage Forms; Pharmaceutical Preparations

Study Officials

• Nagwa A Sabri, phD

  Ainshams university

  PRINCIPAL INVESTIGATOR

• Mohammed M Hussein, Msc student

  Ainshams university

  PRINCIPAL INVESTIGATOR

• Mohamed A Raslan

  Drug Research Centre, Cairo, Egypt

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: QC Manager and Clinical pharmacy Msc student

Study Record Dates

• First Submitted: September 12, 2019
• First Posted: September 24, 2019
• Study Start: June 11, 2019
• Primary Completion: June 25, 2019
• Study Completion: July 8, 2019
• Last Updated: September 24, 2019

Record last verified: 2019-09

Locations

EG (1)