A Study in Healthy Subjects to Evaluate Pharmacokinetics and Food Effect After Dosing of GS-248

Inclusion Criteria

• Willing and able to give written informed consent for participation in the study.
• Healthy male or female subject aged ≥ 18 and ≤70 years.
• Body Mass Index (BMI) ≥ 19.0 and ≤ 30.0 kg/m2.
• Clinically normal medical history, physical findings, vital signs, ECG and laboratory values at the time of screening, as judged by the Investigator.
• Women of child bearing potential (WOCBP) must practice abstinence from heterosexual intercourse (only allowed when this is the preferred and usual lifestyle of the subject) or must agree to use a highly effective method of contraception with a failure rate of 140 mmHg, or
• Diastolic blood pressure 90 mmHg, or
• Pulse 90 bpm
• Positive test for serum hepatitis B surface antigen (HBsAg), hepatitis C virus antibodies (HCVAb) or HIV 1 and/or 2 antibodies at screening.
• Presence or history of drug and/or alcohol abuse and/or excessive intake of alcohol and/or history, or current use, of anabolic steroids, as judged by the Investigator.
• Positive test for drugs of abuse or alcohol at screening or on admission to the unit prior to administration of the IMP.
• Participation in other interventional studies within 3 months prior to administration of study drug.
• Consumption of grapefruit, grapefruit juice, other grapefruit-containing products, or Seville oranges within 14 days of first IMP administration.
• Any clinically significant illness, medical/surgical procedure or trauma within 4 weeks of the first administration of IMP.
• Malignancy within the past 5 years with the exception of in situ removal of basal cell carcinoma.
• Any planned major surgery within the duration of the study.
• Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG, as judged by the Investigator.
• Current smokers or users of nicotine products. Irregular use of nicotine (e.g., smoking, snuffing, chewing tobacco) less than three times per week is allowed before screening visit.
• Regular excessive caffeine consumption defined by a daily intake of >5 cups of caffeine-containing beverages.
• Intake of xanthine- and/or taurine-containing energy drinks within 2 days prior to screening and prior to IMP administration.
• Plasma donation within one month of screening or blood donation (or corresponding blood loss) during three months prior to screening.
• Investigator considers the subject unlikely to comply with study procedures, restrictions and requirements.
• Estimated glomerular filtration rate (eGFR) < 50 mL/min/1.73 m2 (determined by the revised Lund-Malmö GFR estimating equation).
• Subjects with swallowing disorders, which may affect the subject´s capability to swallow the IMP.
• Subjects who are vegetarian or for other reasons cannot eat the high-fat high-calorie breakfast.