The Boceprevir and Sildenafil Pharmacokinetics Study

NCT01499498 | Completed Phase 1 Results

• 1 other identifier: BOC_PK
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This is a healthy volunteer study looking at the interactions between two drugs: boceprevir and sildenafil. New drugs are being developed to treat people with the chronic viral infection hepatitis C. Very little is know how these new treatments interact with other medications such as the drugs used to treat erectile dysfunction. The purpose of this study is to look at levels of both a new hepatitis C drug called boceprevir (BOC) and an existing erectile dysfunction drug called sildenafil to see if they affect the blood levels of each other when given separately and together.

Conditions

Hepatitis C

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (4)

• Sildenafil Alone Maximum Plasma Concentration

  Single dose sildenafil 25mg will be administered with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)

  Day 1

• Boceprevir Alone Maximum Plasma Concentration

  Day 10 commence BOC 800mg three times a day with food. On day 15 at steady state, subjects will attend for witnessed dosing and an intensive pharmacokinetic visit over 8 hours (samples drawn 0, 0.5, 1, 2, 3, 4, 6 and 8 hours post dose)

  day 10-15

• Sildenafil Maximum Plasma Concentration

  administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)

  Day 16

• Boceprevir Maximum Plasma Concentration

  administer BOC 800mg and single dose sildenafil 25mg with food. Intensive pharmacokinetic sampling will be taken over a 24 hour period (0, 0.5, 1, 2, 3, 4, 6, 8, 10, 12 and 24 hours post dose)

  Day 16

Secondary Outcomes (1)

• Number of Patients With Adverse Events

  Day 1 - 16

Study Arms (1)

Sildenafil and Boceprevir

EXPERIMENTAL

Healthy volunteers

Drug: Sildenafil and Boceprevir

Interventions

Sildenafil and Boceprevir DRUG

25mg once/800mg three times a day

Also known as: Viagra and Victrelis

Sildenafil and Boceprevir

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• The ability to understand and sign a written informed consent form, prior to participation in any screening procedures and must be willing to comply with all study requirements.
• Subjects in good health upon medical history, physical exam, and laboratory testing and BMI \<32.
• Subjects who are heterosexually active must use two forms of barrier contraception (e.g., condom with spermicide) during heterosexual intercourse, from screening through completion of the study including 10 days following last dose of study drug.
• Have no serologic evidence of HIV or HCV infection through antibody testing at screening.
• Have screening laboratory results (haematology, chemistry) that fall within the normal range of the central laboratory's reference ranges unless the results have been determined by the Investigator to have no clinical relevance

You may not qualify if:

• Any serious or active medical or psychiatric illness which, in the opinion of the Investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include any active clinically significant renal, cardiac, hepatic, pulmonary, vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy.
• Previous participation in an investigational trial involving administration of any investigational compound within 1 month prior to the study screening.
• Clinically relevant alcohol or drug use (positive drug screen) or history of alcohol or drug use considered by the Investigator to be sufficient to hinder compliance with treatment, follow-up procedures or evaluation of adverse events. Smoking is permitted, but tobacco intake should remain consistent throughout the study.
• Any medication taken listed in protocol including over-the-counter medications and herbal products within 21 days of commencing study drug dosing with the exception of vitamins and/or paracetamol. When a concomitant medication is necessary, this will be reviewed by the Investigator and if not contraindicated, may be continued at the same dose and frequency during the study period.
• History of drug sensitivity or drug allergy which in the opinion of the investigator may put the subject at increased risk of drug reactions during the study.
• Subjects with female partners who are pregnant will not be allowed to enter the study

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

Location

MeSH Terms

Conditions

Hepatitis C

Interventions

Sildenafil Citrate; N-(3-amino-1-(cyclobutylmethyl)-2,3-dioxopropyl)-3-(2-((((1,1-dimethylethyl)amino)carbonyl)amino)-3,3-dimethyl-1-oxobutyl)-6,6-dimethyl-3-azabicyclo(3.1.0)hexan-2-carboxamide

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

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

Results Point of Contact

• Title: Dr Borja Mora Peris
• Organization: Imperial College London

b.mora-peris@imperial.ac.uk

020 3312 6789

Study Officials

• Alan Winston, MBChB MD

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2011
• First Posted: December 26, 2011
• Study Start: December 1, 2012
• Primary Completion: April 1, 2013
• Study Completion: May 1, 2014
• Last Updated: June 21, 2019
• Results First Posted: November 7, 2014

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)