Drug-Drug Interaction Study: ASP2151 and Ritonavir
Condition: Healthy
Intervention: ASP2151; ritonavir
Intervention MeSH terms: Ritonavir
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 48.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HSV; HIV; Herpes; volunteers; drug-drug interaction

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).
    

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.