Overview

Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers

Status:
Completed
Trial end date:
2019-08-06
Target enrollment:
0
Participant gender:
All
Summary
Study to assess the pharmacokinetics of plasma doravirine once daily over 72 hours following drug intake cessation at steady-state in healthy volunteers
Phase:
Phase 1
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Chelsea and Westminster NHS Foundation Trust
Collaborators:
Imperial College London
Merck Sharp & Dohme Corp.
University of Liverpool
Criteria
Inclusion Criteria:

1. The ability to understand and sign a written informed consent form, prior to
participation in any screening procedures and must be willing to comply with all study
requirements

2. Male or non-pregnant, non-lactating females.

3. Between 18 to 65 years, inclusive

4. Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive

5. ALT, alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is
acceptable if bilirubin is fractionated and direct bilirubin <35%). A single repeat is
allowed for eligibility determination.

6. Women of childbearing potential must be using an adequate method of contraception to
avoid pregnancy throughout the study and for a period of at least 4 weeks after the
study. Any contraception method must be used consistently, in accordance with the
approved product label and for at least 4 weeks after discontinuation of IMP.

7. Men who have partners who are women of childbearing potential must be using an
adequate method of contraception to avoid pregnancy in their partner throughout the
study and for a period of at least 4 weeks after the study. Any contraception method
must be used consistently, in accordance with the approved product label and for at
least four weeks after discontinuation of IMP.

8. Willing to consent to their personal details being entered onto the TOPS database

9. Willing to provide proof of identity by photographic ID at screen and any subsequent
visit

10. Registered with a GP in the UK

Exclusion Criteria:

1. Any clinically significant acute or chronic medical illness

2. Evidence of organ dysfunction or any clinically significant deviation from normal in
physical examination, vital signs, ECG or clinical laboratory determinations

3. Positive blood screen for hepatitis B surface antigen or C antibody

4. Positive blood screen for HIV-1 or 2 by antibody/antigen assay

5. Current or chronic history of liver disease, or known hepatic or biliary abnormalities
(with the exception of Gilbert's syndrome or asymptomatic gallstones)

6. History or presence of allergy to the study drugs and their components

7. Current or recent (within three months) gastrointestinal disease

8. Known intolerance of lactose monohydrate, sunset yellow aluminium lake (E110), and
patients with galactose intolerance, the Lapp lactase deficiency, or glucose-galactose
malabsorption

9. Clinically relevant alcohol or drug use (positive urine drug screen) or history of
alcohol or drug use considered by the Investigator to be sufficient to hinder
compliance with treatment, follow-up procedures or evaluation of adverse events.
Smoking is permitted, but tobacco intake should remain consistent throughout the study

10. Exposure to any investigational drug (or placebo) or participation in a clinical study
involving the donation of blood samples within three months of first dose of study
drug

11. Use of any other drugs (unless approved by the Investigator), including
over-the-counter medications and herbal preparations, within two weeks prior to first
dose of study drug, unless approved/prescribed by the Principal Investigator as known
not to interact with study drugs.

12. Females of childbearing potential without the use of effective non-hormonal birth
control methods, or not willing to continue practising these birth control methods for
at least four weeks after the end of the treatment period