A study to evaluate safety and tolerability of GS -5801 in healthy subjects

Phase 1

• Conditions: Hepatitis B Virus; Infection - Other infectious diseases; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12616001260415
• Lead Sponsor: Gilead Sciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-08
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

1. Have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures.
2. Be aged 18 through 45 years of age, inclusive at screening
3. Be a nonsmoker. The use of nicotine or nicotine-containing products must be discontinued 90 days prior to the first dose of study drug
4. Have a calculated body mass index (BMI) of >=19.0 and =<30.0 kg/m2 at screening
5. Have a creatinine clearance (CLcr) =>90 mL/min (using the Cockcroft-Gault method based on serum creatinine and actual body weight as measured at screening, ie,
Male: (140 – Age [years]) x (Weight [kg]) / 72 x (Serum Creatinine [mg/dL]) = CLcr (mL/min)
Female: ((140 – Age [years]) x (Weight [kg]) / 72 x (Serum Creatinine [mg/dL])) x 0.85 = CLcr (mL/min)
6. Females of childbearing potential must have a negative serum pregnancy test at screening and clinic admission
7. Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
8. Male subjects must refrain from sperm donation from clinic admission (eg, Day -1),
throughout the study period, and continuing for at least 90 days following the last dose of study drug
9. Subjects have not donated blood within 56 days of study entry or plasma within 7 days of study entry and must refrain from blood donation from clinic admission, throughout the study period, and continuing for at least 30 days following the last dose of study drug.
10. Screening laboratory and 12-lead ECG evaluations must be without clinically significant abnormalities as assessed by the investigator
11. Have liver disease or liver function tests such as alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, and total bilirubin below the upper limit of normal at screening
12. Have either a normal 12-lead ECG or one with abnormalities that are considered clinically insignificant by the investigator in consultation with the sponsor
13. Must be willing and able to comply with all study requirements
14. Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs.

Exclusion Criteria

1. Be a pregnant or lactating female
2. Have received any study drug within 30 days prior to study dosing
3. Have current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance or subject safety
4. Have a positive test result for human immunodeficiency virus type 1 (HIV-1) antibody,
hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody
5. Have poor venous access that limits phlebotomy
6. Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, with the exception of vitamins, fish oil, protein powder, and/or paracetamol and/or ibuprofen and/or hormonal contraceptive medications
7. Have been treated with systemic steroids, immunosuppressant therapies, or chemotherapeutic agents within 3 months prior to screening or is expected to receive these agents during the study (eg, corticosteroids, immunoglobulins, and other immune- or cytokine-based therapies)
8. Significant serious skin disease, such as but not limited to rash, food allergy, eczema,
psoriasis, or uticaria
9. Significant drug sensitivity or drug allergy (such as anaphylaxis or hepatoxicity)
10. Known hypersensitivity to the study drugs their metabolites or to formulation excipients
11. Significant cardiac disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction < 40%), a family history of long QT syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
12. Syncope, palpitations, or unexplained dizziness
13. Implanted defibrillator or pacemaker
14. Liver disease, including Gilbert disease
15. Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid
hypersecretory conditions requiring prolonged (> 6 months) medical treatment.
16. Medical or surgical treatment that permanently altered gastric absorption (eg, gastric or intestinal surgery). A history of cholecystectomy is not exclusionary.
17. Have any serious or active medical or psychiatric illness (including depression) that, in the opinion of the investigator, would interfere with subject treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary
(including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified