Drug-Drug Interaction Study: ASP2151 and Montelukast
Condition: Healthy
Intervention: Montelukast; ASP2151
Intervention MeSH terms: Montelukast
Phase: Phase 1
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 24.0
Sex: Male
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: HSV; Herpes; volunteers; drug-drug interaction

Summary:

      CYP2C8 is involved in the metabolism of many drugs. So, it is important to assess in vivo the
      inhibitory effect of ASP2151 on that enzyme to determine any possible drug interactions. The
      aim of this trial is to investigate the potential for interaction of ASP2151 with the CYP2C8
      probe substrate montelukast.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A body mass index (Quetelet index) in the range 18.0-30.9.

          -  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.

          -  Willingness to give written consent to have data entered into The Overvolunteering
             Prevention System.

        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, CYP2C19, CYP2C8 or CYP2C9 metabolic pathway (unless judged
             as not clinical significant by the investigator and sponsor). See Appendix 1: for
             common CYP3A4, CYP2C19, CYP2C8 and CYP2C9 interactors/substrates.

          -  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.

          -  Presence or history of drug or alcohol abuse, or intake of more than 21 units of
             alcohol weekly or more than 10 cigarettes daily.

          -  Blood pressure and heart rate 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.
             However, if the investigator deems the result to be not clinically significant the
             subject may be included.

          -  Possibility that the volunteer will not cooperate with the requirements of the
             protocol.

          -  Evidence of drug abuse on urine testing.

          -  Positive test for hepatitis B, hepatitis C, HIV1 or HIV2.

          -  Loss of more than 400 mL blood during the 3 months before the trial, eg as a blood
             donor.

          -  Objection by General Practitioner (GP) to volunteer entering trial.