Drug-Drug Interaction Study: ASP2151 and Ritonavir

NCT ID: NCT02223351

Last Updated: 2019-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2014-12-31

Brief Summary

ASP2151 is an experimental treatment for herpes. HIV infected people are susceptible to contracting other infections because of their compromised immune system. As HIV patients will be taking drugs to treat the virus this study aims to see if ASP2151 would interact with one of the drugs that is commonly prescribed to HIV patients (ritonavir).

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

400mg ASP2151

400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir

Group Type: OTHER

ASP2151

Intervention Type: DRUG

ritonavir

Intervention Type: DRUG

1200mg ASP2151

1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir

Group Type: OTHER

ASP2151

Intervention Type: DRUG

ritonavir

Intervention Type: DRUG

Interventions

ASP2151

Intervention Type: DRUG

ritonavir

Intervention Type: DRUG

Other Intervention Names

Norvir

Eligibility Criteria

Inclusion Criteria

• Healthy volunteers
• Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
• Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or his delegate.

Exclusion Criteria

• Clinically relevant abnormal history, physical findings, ECG, or laboratory values at the pre-trial screening assessment that could interfere with the objectives of the trial or the safety of the volunteer.
• Any of the following liver function tests higher than 1.5 times the ULN at the screening visit: aspartate aminotransferase (AST), alanine aminotransferase (ALT), ALP, bilirubin, gamma glutamyl transpeptidase (gamma-GT).
• Platelet counts outside normal limits.
• Presence of acute or chronic illness or history of chronic illness sufficient to invalidate the volunteer's participation in the trial or make it unnecessarily hazardous.
• Clinically significant impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease, or history of any psychotic mental illness.
• History of bleeding diathesis.
• Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines.
• Presence or history of severe adverse reaction to any drug, history of multiple drug allergies (multiple defined as >3), or sensitivity to trial medication.
• Use, during the 28 days before the first dose of trial medication, of any prescription medicine, or any other medicine or herbal remedy (such as St John's wort) known to interfere with the CYP3A4 metabolic pathway (unless judged as not clinical significant by the investigator and sponsor).
• Use, during the 7 days before the first dose of trial medication, of any over-the-counter medicine, with the exception of paracetamol (acetaminophen).
• Participation in another clinical trial of a new chemical entity or a prescription medicine within the previous 3 months.
• Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood donor.
• Presence or history of drug or alcohol abuse, or intake of more than 21 units of alcohol weekly or more than 10 cigarettes daily.
• Evidence of drug abuse on urine testing.
• Positive test for hepatitis B, hepatitis C, HIV1 or HIV2.
• Blood pressure (BP) and heart rate (HR) in seated position at the screening examination outside the ranges 90-140 mm Hg systolic, 40-90 mm Hg diastolic; heart rate 40_100 beats/min.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Maruho Europe Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hammersmith Medicines Research Ltd

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

2014-002174-37

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

M522101-EU22

Identifier Type: -

Identifier Source: org_study_id