Overview

Drug-Drug Interaction Study: ASP2151 and Montelukast

Status:
Completed
Trial end date:
2015-04-01
Target enrollment:
0
Participant gender:
Male
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Maruho Europe Limited
Treatments:
Montelukast
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.