CMV infection virus infection
Conditions
Sponsors
Merck Sharp & Dohme (MSD)
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Be a non-pregnant and non-breast feeding female of 18 to 55 years of age (inclusive) at the screening visit, further:;a. [Females of childbearing potential] Demonstrate a serum beta-human chorionic gonadotropin (ß-hCG) level consistent with the non-gravid state at the pre-trial (screening) visit and must agree to abstain from heterosexual intercourse, use a double-barrier local contraception method (e.g., spermicidal gel plus condom), or intra-uterine device (IUD) combined with another allowed contraceptive method, for the entire duration of the trial, until 4 weeks after the last dose of trial drug.;b. [Females of non-childbearing potential] Be postmenopausal without menses for at least 1 year and has an follicle stimulating hormone (FSH) value in the postmenopausal range upon pre-trial (screening) evaluation, and/or is status post hysterectomy, oophorectomy,or tubal ligation, based on the subject's recall of their medical history. Information must be captured appropriately within the clinical site's source documents. 2. Have a Body Mass Index (BMI) between 18.0 and 32.0 kg/m^2 (inclusive) at the screening visit. BMI is calculated according to QPS SOP's. 3. Be judged by the investigator to be in good health based on medical history, physical examination, vital signs measurements, ECG recording and laboratory safety tests performed at the screening visit and/or prior to administration of the initial dose of study drug. 4. Be a nonsmoker or has not used nicotine or nicotine-containing products for at least 3 months prior to screening. 5. Understand the study procedures and agree to participate in the study by giving written informed consent. 6. Is willing to comply with the study restrictions. 7. Subjects provide written informed consent/assent for the trial, including for Future Biomedical Research.
Exclusion criteria
Exclusion criteria: 1. Has a history of HIV, hepatitis B/C, liver injury, clinically significant hepatic abnormalities or disease or was confirmed positive by serology test during screening. 2. Has a confirmed positive serum pregnancy test or is reastfeeding. 3. Is mentally or legally incapacitated, has significant emotional problems at the time of the screening visit or expected during the conduct of the study or, in the opinion of the investigator, has a history of a clinically significant psychiatric disorder. 4. Has a history of any illness that, in the opinion of the study investigator, might confound the results of the study or poses an additional risk to the subject by their participation in the study. 5. Has a history of clinically significant endocrine, dermatological, neurological, psychiatric, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary diseases. 6. Has an estimated creatinine clearance (CLCr) of <=80 mL/min at pre-trial (screening) visit based on the Cockcroft-Gault equation; the Cockcroft-Gault equation is as follows: CLCr = 0.85 x (((140-age [yr])(body weight [kg]))/ ((72)(serum creatinine [mg/dL]))) When creatinine is measured in µmole/litre, use the following formula: CLCr = 0.85 x (((140-age [yr])(body weight [kg]) x constant)/ ((72)(serum creatinine [µmole/L]))) An actual CLCr, as determined by a 24-hour urine collection, may be used in place of, or in conjunction with, the Cockcroft-Gault equation 7. Has a history of neoplastic disease. Exception: Subjects with adequately treated (with at least 5 years of non-relapse recurrence) non-melanomatous skin carcinoma may participate in the study. 8. Has a history of regular alcohol consumption exceeding 21 drinks/week (1 drink = 5 ounces [150 mL] of wine or 12 ounces [360 mL] of beer or 1.5 ounces [45 mL] of hard liquor). 9. Consumes excessive amounts, defined as greater than 6 servings (1 serving is approximately equivalent to 120 mg of caffeine) of coffee, tea, cola, or other caffeinated beverages per day. 10. Has had major surgery within 6 months of first dose, donated or lost 1 unit of blood (approximately 500 mL) within at least 90 days prior to dosing. 11. Has received an investigational study drug within 3 months prior to first dose. 12. In the opinion of the investigator, has a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food. 13. Has known sensitivity to the study drug or any excipients used in the tablet composition. 14. Is currently a regular user (including "recreational use") of any illicit drugs or has a history of drug (including alcohol) abuse within approximately 6 months or has a positive urine drug screen or alcohol breath test at the pre-trial (screening) visit or on any admission. 15. Is being considered inappropriate for participation in the study or there is any concern by the investigator regarding the safe participation of the subject in the study. 16. Is unable to refrain from or anticipates the use of any medication, including prescription and non-prescription drugs or herbal remedies (such as St. John*s Wort [Hypericum perforatum]). Use of medication that are known to significantly (strong or moderate) inhibit or induce liver enzymes involved in dr
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetics | — |
Secondary
| Measure | Time frame |
|---|---|
| - Pharmacokinetics - Safety - Tolerabililty | — |
Countries
Netherlands
Outcome results
None listed