A Study of Tadalafil in Benign Prostatic Hyperplasia

NCT01183650 | Completed Phase 1 Results

• 2 other identifiers: 13910H6D-MC-LVIY
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the pharmacokinetics of tadalafil in Japanese and non-Japanese men with Benign Prostatic Hyperplasia (BPH). The safety of tadalafil will also be studied.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (3)

• Pharmacokinetics: Area Under the Concentration Curve (AUC) for Tadalafil and Metabolite IC710

  AUC for Day 1 is reported as AUC(tau \[t\], day 1), which is AUC from time zero to 24 hours (t) postdose on Day 1. AUC for Day 10 is reported as AUC(t,steady state \[ss\]), which is AUC during one 24-hour dosing interval at steady-state.

  1 day and 10 days

• Pharmacokinetics: Concentration Maximum (Cmax) of Tadalafil and Metabolite IC710

  1 day and 10 days

• Pharmacokinetics: Time to Concentration Maximum (Tmax) of Tadalafil and Metabolite IC710

  1 day and 10 days

Study Arms (1)

Tadalafil

EXPERIMENTAL

5 mg, administered orally, daily for 10 days

Drug: Tadalafil

Interventions

Tadalafil DRUG

5 mg, administered orally, daily for 10 days

Also known as: LY450190, Cialis, Adcirca

Tadalafil

Eligibility Criteria

• Age: 45 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have had lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH-LUTS) (as diagnosed by a qualified physician) \>6 months at screening visit. Lower urinary tract symptoms (LUTS) include those associated with voiding (obstructive symptoms, such as incomplete emptying, intermittency, weak stream, straining) and/or storage (irritative symptoms, such as frequency, urgency, nocturia).
• Have BPH-LUTS with moderate-to-severe symptoms confirmed by an International Prostate Symptom Score (IPSS) \>12. (The IPSS total score is defined as the sum of Questions 1 through 7 and does not include the IPSS Quality of Life.)
• Taking into account the age and disease status, subjects determined to be in good health according to medical history, physical examination, electrocardiogram (ECG), and laboratory safety assessments.
• Body mass index between 18 and 30 kg/m\^2 inclusive.
• Agree not to use any other approved or experimental pharmacologic BPH, erectile dysfunction (ED), and/or overactive bladder (OAB) treatments, including alpha blockers, phosphodiesterase type 5 (PDE5) inhibitors, or herbal preparations at least 1 week prior to dosing and through to follow-up.
• Subjects with a serum prostate-specific antigen (PSA) \<10.0 ng/mL. Subjects with a serum PSA greater than or equal to 4.0 and \<10.0 ng/mL must have documentation of a negative histologic biopsy of carcinoma of the prostate within 12 months prior to screening.

You may not qualify if:

• History of radical prostatectomy, or other pelvic surgery or procedure, including any pelvic surgical procedure on the urinary tract apart from transurethral resection, pelvic surgery for malignancy or bowel resection, or a history of lower urinary tract malignancy or trauma. History of urinary retention or lower urinary tract (bladder) stones within 6 months of screening.
• Current or previous history of malignant disease of the prostate.
• Concomitant treatment with or ingestion of cytochrome P 450 3A4 (CYP3A4)-inducing or -inhibiting agents from 2 weeks prior to dosing and through the end of the study. Including herbal/food and other supplements, fruit, or fruit juices containing grapefruit or pomegranate components.
• History of loss of vision in one eye because of nonarteritic anterior ischemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure.
• Subjects with chronic stable angina treated with long-acting nitrates, subjects with chronic stable angina who required short-acting nitrates in the 90 days prior to screening visit, or subjects with angina occurring during sexual intercourse in the 6 months prior to screening.
• Subjects having met the criteria for unstable angina within 6 months prior to screening, history of myocardial infarction or coronary artery bypass graft surgery within 90 days prior to screening, or percutaneous coronary intervention (for example, angioplasty or stent placement) within 90 days prior to screening.
• Any evidence of heart disease (New York Heart Association \[NYHA\] greater than or equal to Class III) within 6 months of screening.
• A history of cardiac arrest.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Munich, 80636, Germany

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tadalafil

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carbolines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indole Alkaloids; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2010
• First Posted: August 17, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: May 16, 2012
• Results First Posted: May 16, 2012

Record last verified: 2012-04

Locations

DE (1)