GS-US-200-5710: A Phase 1 Study in Healthy Participants to Evaluate the Safety,Tolerability, and Pharmacokinetics of Subcutaneous andIntramuscular Lenacapavir
- Conditions
- HIVInfection - Acquired immune deficiency syndrome (AIDS / HIV)
- Registration Number
- ACTRN12623000536662
- Lead Sponsor
- Gilead Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 50
Be aged 18 through 55 years, inclusive at screening.
Be a nonsmoker. The use of nicotine-containing products must be discontinued 42 days prior
to the administration of study drug.
Have a calculated body mass index (BMI) no greater than 35.0 kg/m2 at screening.
Have a creatinine clearance (CLcr) at least 90 mL/min (using the Cockcroft-Gault method
{Cockcroft 1976}) based on serum creatinine and actual body weight, as measured at
screening,
Men and women of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception.
Participants 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 confinement period, and continuing for at least 253 days following the administration of study drug.
Screening laboratory evaluations and 12-lead ECG evaluations must be without clinically
significant abnormalities as assessed by the investigator.
Have liver biometric tests of alanine aminotransferase (ALT), aspartate aminotransferase
(AST), alkaline phosphatase, and total bilirubin below or equal to the upper limit of normal
at screening.
Must be willing and able to comply with all study requirements.
Must, in the opinion of the investigator, be in good health based upon medical history and
physical examination, including vital signs.
Positive serum or urine pregnancy test
Breastfeeding woman.
Is currently participating in or has participated in an interventional clinical study with an
investigational medicinal product administered within 30 days prior to study dosing on Day 1 through the duration of the study.
Has a tattoo or other dermatological condition overlying the injection site which in the
opinion of the investigator, may interfere with interpretation of ISRs.
Have current alcohol or substance abuse judged by the investigator to potentially interfere
with participant compliance or participant safety, or a positive drug or alcohol test at
screening or baseline.
Have a positive test result for HIV at screening (antigen/antibody test) or Day -1 (rapid test).
Have a positive test result for hepatitis B surface antigen (HBsAg), or hepatitis C virus
(HCV) antibody at screening.
Assessed by the investigator as being at risk for HIV infection in the past 6 months.
This may include, but not limited to, one or more of the following risk factors:
(a) unprotected vaginal or anal sex with a person with HIV; (b) sex work for money or drugs;
(c) sexually transmitted infection; (d) injection of nonprescribed drugs for recreational use;
(e) post- or pre-exposure prophylaxis (PEP or PrEP).
Have poor venous access that limits phlebotomy.
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 and/or acetaminophen and/or ibuprofen and/or hormonal contraceptive medications.
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.
Have a history of: Significant serious skin disease, Significant drug sensitivity or drug allergy, Known hypersensitivity to the study drugs, their metabolites, or to formulation excipients, Significant cardiac disease, Syncope, palpitations, or unexplained dizziness. Implanted defibrillator or pacemaker. Liver disease, including Gilbert syndrome. Severe peptic ulcer disease, gastroesophageal reflux disease, or other gastric acid
hypersecretory conditions requiring prolonged (> 6 months) medical treatment.
Have any serious or active medical or psychiatric illness (including depression) that, in the
opinion of the investigator, would interfere with participant treatment, assessment, or
compliance with the protocol.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method