Bioavailability of MK-1439 nano formulations in heathy subjects
Research type
Research Study
Full title
A Rapid Pharmacokinetic Trial of the Bioavailability of Four MK-1439 Nano Formulations in Healthy Adults
IRAS ID
186623
Contact name
Annelize Koch
Contact email
Sponsor organisation
Merck Sharp & Dohme Corp.,a subsidiary of Merck & Co., Inc
Eudract number
2015-002702-36
Duration of Study in the UK
0 years, 2 months, 29 days
Research summary
Before a new medicine can be approved for use in humans, it is necessary to confirm that it is safe and effective. This is done by carrying out research studies (or clinical studies) such as this one. This study will recruit healthy, non-smoking, males and females between the ages of 18 and 55 years.
The study drug does not yet have a name and it is not yet licensed. It is only known by the number MK-1439. Doravirine is the planned generic name.
It is hoped that the study drug will be useful as a treatment for HIV-1. The study drug have been given to 543 adult subjects in single doses of up to 1200 mg and as multiple doses up to 750 mg once daily.
The purpose of this study is to:
-Compare the bioavailability (the amount of unchanged study drug that reaches the bloodstream) of four MK-1439 experimental nano formulations (Type 1-4) to a MK-1439 100 mg film coated tablet in healthy subjects.The bioavailability indicates the amount of unchanged MK-1439 that reaches the blood circulation which is available to the body. The bioavailability is comparable, if the concentrations in the blood during a time period are the same or similar for both tablet and nano formulations. Therefore, blood samples will be collected at planned intervals after administration of each of the nano formulations and tablet formulation to measure its concentration (Pharmacokinetic [PK] samples).
-See how safe the study drug formulations are and how well they are tolerated after dosing.
-Understand why different people respond differently to the same drug through DNA testing and Future Biomedical Research (FBR).Vital signs, safety ECG measurements, safety laboratory assessments, adverse events and concomitant medications will be monitored throughout the entire investigational period. Blood samples for pharmacokinetic & genetic analysis will be collected.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
15/SC/0466
Date of REC Opinion
28 Aug 2015
REC opinion
Favourable Opinion