Drug-Drug Interaction Study: ASP2151 and Ritonavir

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: ASP2151
Drug: ritonavir

Registration Number: NCT02223351

Lead Sponsor: Maruho Europe Limited

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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 48

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
400mg ASP2151	ASP2151	400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir
1200mg ASP2151	ASP2151	1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir
400mg ASP2151	ritonavir	400mg ASP2151 alone followed by 400mg ASP2151 + 600mg ritonavir
1200mg ASP2151	ritonavir	1200mg ASP2151 alone followed by 1200mg ASP2151 + 600mg ritonavir

Primary Outcome Measures

Name	Time	Method
Apparent Total Body Clearance (CL/F) of ASP2151 From Plasma	Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
Peak Plasma Concentration (Cmax) of ASP2151	Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
Area Under the Curve (AUC) of ASP2151	Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
Time of Peak Concentration (Tmax) of ASP2151	Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
Apparent Volume of Distribution (Vd/F) of ASP2151	Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention
Half-Life (t1/2) of ASP2151	Blood samples were taken at pre-dose of Day 1 and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, 48 and 72h after post doses in first or second intervention