| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
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| E.1.1.1 | Medical condition in easily understood language |
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| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 19.0 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10020161 |
| E.1.2 | Term | HIV infection |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
1.To evaluate the comparative bioavailability of the MK-1439 100 mg adult formulation tablets under fasting conditions to MK-1439 100 mg investigational oral pediatric uncoated and coated granules, 0.8 mg per granule [100 mg total dose], under fasting conditions
2.To evaluate the comparative bioavailability of the MK- 1439 100 mg investigational oral pediatric uncoated granule formulation, 0.8 mg per granule [100 mg total dose], under fasting conditions to MK-1439 100 mg investigational oral pediatric uncoated granules, 0.8 mg per granule [100 mg total dose], under fasting conditions, when given with vanilla pudding or applesauce
3.To evaluate the comparative bioavailability of the MK- 1439 100 mg investigational oral pediatric coated granules, 0.8 mg per granule [100 mg total dose], under fasting conditions to MK-1439 100 mg investigational oral pediatric coated granules, 0.8 mg per granule [100 mg total dose], under fasting conditions when given with vanilla pudding or applesauce
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| E.2.2 | Secondary objectives of the trial |
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| E.2.3 | Trial contains a sub-study | Yes |
| E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
| The Sponsor will conduct Future Biomedical Research on DNA specimens collected for future biomedical research during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting/retaining specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs/vaccines, and/or to ensure that subjects receive the correct dose of the correct drug/vaccine at the correct time. |
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| E.3 | Principal inclusion criteria |
1) Healthy, non-smoking, male and female subjects, from 18 to 55 years of age.
2) BMI ≥19.0 and ≤30.0 kg/m2.
3) No clinically significant findings in vital signs measurements.
4) No clinically significant findings in a 12-lead electrocardiogram (ECG).
5) No clinically significant abnormal laboratory values.
6) Have no significant diseases.
7) Willing to use an acceptable, effective method of contraception.
8) Subjects provide written informed consent/assent for the trial, including for Future Biomedical Research.
9) Have no clinically significant findings from a physical examination.
10) Must be able to consume pudding and applesauce and be able to consume a serving of each, without chewing, in 10 minutes or less at screening.
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| E.4 | Principal exclusion criteria |
1) Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, gastrointestinal, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
2) Known or suspected carcinoma.
3) Known history or presence of hypersensitivity or idiosyncratic reaction to MK-1439 or any other drug substances with similar activity.
4) 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.
5) Mentally or legally incapacitated, has significant emotional problems at the time of screening or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder over the last 5 years. Subjects who have had situational depression may be enrolled in the study at the discretion of the investigator.
6) Subjects with permanent or removable mouth piercing or non-removable mouth piercings, dentures, braces, dental appliances, or any other alteration to the mouth that may compromise drug delivery.
7) History of any surgery on the oral cavity or throat in the past year.
8) Known history or presence of galactose or fructose intolerance, sucraseisomaltase insufficiency, Lapp lactase insufficiency, galactosemia, or glucose-galactose malabsorption syndrome.
9) Presence of hepatic or renal dysfunction.
10) Estimated creatinine clearance of ≤80 mL/min based on the Cockcroft- Gault equation.
11) History of malabsorption within the last year.
12) Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
13) History of drug or alcohol addiction requiring treatment.
14) Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
15) Positive test result for urine drugs of abuse (cannabinoids, opiates, amphetamines, cocaine, phencyclidine, tricyclic antidepressants, barbiturates, methadone, and benzodiazepines) or urine cotinine.
16) Difficulty fasting or consuming standard meals.
17) Does not tolerate venipuncture.
18) Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
19) Females who:
• Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within 6 months prior to dosing;
• Have discontinued or changed the use of oral or patch hormonal contraceptives within 1 month prior to drug administration;
• Are pregnant (serum hCG consistent with pregnancy); or
• Are lactating.
20) Donation or loss of whole blood (including clinical trials):
• ≥50 mL and <500 mL within 30 days prior to drug administration;
• ≥500 mL within 56 days prior to drug administration.
21) Participated in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recently participated in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
22) On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).
23) Have had a tattoo or body piercing within 30 days prior to drug administration.
24) Use of any enzyme-modifying drugs known to induce/inhibit hepatic drug metabolism or alter gastrointestinal pH/movement (e.g., omeprazole, ranitidine) within 30 days prior to drug administration.
In addition to the above, subjects may be excluded from participating in the study due to any concern by the investigator regarding the safe participation of the subject in the trial or for any other reason if the investigator considers the subject inappropriate for participation in the trial.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
| The following pharmacokinetic parameters will be estimated using a non-compartmental approach for MK-1439: C24, Cmax, Tmax, AUC0-last, AUC0-inf, t1/2, λz, CL/F, and Vz/F |
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| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| Prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours post-dose. |
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| E.5.2 | Secondary end point(s) |
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| E.5.2.1 | Timepoint(s) of evaluation of this end point |
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | No |
| E.6.5 | Efficacy | No |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | No |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | No |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | Yes |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | Yes |
| E.7.1.3.1 | Other trial type description |
| Comparative Bioavailability |
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| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | No |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | No |
| E.8.1.6 | Cross over | Yes |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | No |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
| adult formulation tablets of MK-1439 |
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| E.8.2.4 | Number of treatment arms in the trial | 7 |
| E.8.3 |
Will this trial be conducted at a single site globally?
| Yes |
| E.8.4 | Will this trial be conducted at multiple sites globally? | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Yes |
| E.8.6.3 | Specify the countries outside of the EEA in which trial sites are planned |
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| E.8.7 | Trial has a data monitoring committee | No |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.2 | In all countries concerned by the trial days | 44 |
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