Fosmanogepix in healthy adults: how it may interact with other drugs and heart rhythm

Inclusion Criteria:

* Body mass index of 18 to 30 kg/m2, inclusive, and a total body weight \> 50 kg at screening
* Healthy, as determined by medical history, physical examination, and other procedures, including blood pressure and pulse rate, 12-lead ECG, clinical laboratory tests (hematology, clinical chemistry, coagulation, urinalysis), and an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73m2 (CKD-EPI formula), at Screening and Day -2.
* Women of childbearing potential must agree to use highly effective forms of contraception during treatment and observation.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
* Active infection.
* Any condition possibly affecting drug absorption.
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, HCVAb, and syphilis
* Subjects who are pregnant, breastfeeding, or plan to become pregnant during the study.

Medical history of neurological disorders, including abnormal movements or seizures.

* Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the Investigator's judgment, make the subject inappropriate for the study.
* History of allergy or hypersensitivity or other contraindication to any of the drugs to be administered, or to one of the components of the study drugs, as determined by the Investigator.
* History of risk factors for QT prolongation, Torsades de Pointes, or uncorrected hypokalemia/hypomagnesemia.
* Previous administration of an investigational drug (including a vaccine) within 60 days or five half-lives (whichever is longer) prior to the first study drug administration on Day 1.
* For Part 1 only, poor metabolizers of CYP2D6 (\*4/\*4; \*4/\*5; \*5/\*5), CYP2C9 (\*2/\*2; \*2/\*3; \*3/\*3), and/or CYP2C19 (\*2/\*2) (determined at Screening or from available historical data).
* Supine systolic blood pressure (SBP) \> 140 mmHg or diastolic blood pressure (DBP) \> 90 mmHg, and pulse rate \> 100 beats per minute (bpm) or \< 40 bpm Supine 12-lead ECG demonstrating any of the following clinically-relevant abnormalities that may affect subject safety or interpretation of the study results: QTcF interval \> 450 msec, QRS interval \> 120 msec, complete left bundle branch block, signs of an acute or indeterminate-age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias
* Subjects with AST or ALT \> 1.0 × ULN.
* Blood (excluding plasma) donation or blood loss \> 500 mL within 60 days prior to Screening.
* History of alcohol abuse or binge drinking and/or any other illicit drug abuse or dependence.
* Use of tobacco or nicotine-containing products or devices within 3 months of Screening.
* Caffeine consumption ≥ 800 mg per day at Screening.
* Use of prescription/non-prescription (including vaccines) drugs or dietary/herbal supplements within 21 days (or five half-lives, whichever is longer) prior to Day -2, except for hormonal contraceptives, or paracetamol up to 1,500 mg/day.