Pediatric Formulation Study

Phase 1

• Conditions: HIV – Human Immunodeficiency Virus; MedDRA version: 19.0Level: PTClassification code 10020161Term: HIV infectionSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2016-004728-48-Outside-EU/EEA
• Lead Sponsor: Merck Sharp & Dohme Corp, a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-23
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

1. Non-tobacco using males and non-pregnant females, 18-55 years of age, inclusive.
2. A body mass index (BMI) of 18-30 kg/m² inclusive as calculated according to Novum Standard Operating Procedures.
3. Alkaline phosphatase, alanine transaminase (ALT/SGPT), aspartate transaminase (AST/SGOT), and bilirubin (total and direct) are below the upper limit of normal based on the clinically acceptable normal range; obtained from the clinical laboratory tests performed at screening.
4. If female and of childbearing potential, prepared to abstain from sexual intercourse, or have used and agree to continue to use a reliable method of contraception (e.g., hormonal contraceptives, condom with spermicide, IUD) for at least 30 days before initial dosing and throughout the duration of the study.
5. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
6. Able to consume the entire contents of a 6 oz. container of lowfat vanilla or french vanilla yogurt (e.g., Stonyfield Organic™ Smooth & Creamy lowfat french vanilla yogurt) within 10 minutes, at screening.
7. Signed and dated written informed consent form for the trial, which meets all criteria of current ICH, FDA and state regulations.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 24
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Females who are pregnant, lactating or likely to become pregnant during the study.
2. History of allergy or sensitivity to MK-1439 or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the integrity of study.
3. Lactose intolerant.
4. Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction, especially cardiovascular disorders (angina, heart failure, irregular heartbeats, heart attack, hypertension, hypotension), stroke, renal or hepatic disorder, diabetes or bleeding disorders.
5. Clinically significant history or presence of gastrointestinal disease or malabsorption within the last year, as determined by the Investigator.
6. Presence of a medical condition requiring regular treatment with prescription drugs (except hormonal contraceptives).
7. History of psychiatric disorders occurring within the last two years that required the subject to be hospitalized or treated with medication.
8. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes (e.g., CYP3A4) within 30 days before initial dosing.
9. Receipt of any drug as part of a research study within 30 days before initial dosing.
10. Drug or alcohol addiction requiring treatment in the past 12 months.
11. History of excessive alcohol consumption (on average more than 14 units of alcohol/week) during the past 12 months.
12. Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days before initial dosing.
13. Positive test for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
14. Positive test results for drugs of abuse at screening.
15. If female, has a positive serum pregnancy test at screening.
16. Use of tobacco products, or other nicotine containing products such as patches or gum within 90 days before initial dosing.
17. Difficulty fasting, eating yogurt, or eating the standard meals that will be provided during the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified