None listed
Conditions
Brief summary
This is a Phase 1, multi-centre, international, open-label study to evaluate the safety, tolerability, and pharmacokinetics of subcutaneously and intramuscularly administrated Lenacapavir in healthy participants. This study aims at further finding the drug concentration and dose required to support taking Lenacapavir at least once a year, for use in the prevention of HIV-1 infection.
Interventions
Every participant will be receiving a single dose of either SC or IM administered, Lenacapavir and the does level of Lenacapavir will vary between cohorts with or without an optional 600mg loading oral dose of Lenacapavir on day 1, 2, 8 and/or day 15 based on emerging data from previous cohorts.
Dose cohorts are as follows:
Cohort 1,2,3, 6, 7 and 8 will receive a dosage of up to 2400 mg of LEN via SC day 1
Cohort 4 and 5 will receive a dosage of up to 3200mg LEN via SC day 1
Cohort 11 will recei
Every participant will be receiving a single dose of either SC or IM administered, Lenacapavir and the does level of Lenacapavir will vary between cohorts with or without an optional 600mg loading oral dose of Lenacapavir on day 1, 2, 8 and/or day 15 based on emerging data from previous cohorts. Dose cohorts are as follows: Cohort 1,2,3, 6, 7 and 8 will receive a dosage of up to 2400 mg of LEN via SC day 1 Cohort 4 and 5 will receive a dosage of up to 3200mg LEN via SC day 1 Cohort 11 will receive a dosage of up to 2400 mg of LEN via IM, only on Day 1 Cohort 12 will receive a dosage of up to 5000 mg of LEN via IM, with an optional tablet loading oral dosage of 600 mg of LEN on Day 1 and day 2. Cohort 13, 14, 15, 16 & 17 will receive a dosage of up to 5000 mg of LEN via SC or IM, with an optional tablet loading oral dosage of 600 mg of LEN on Day 1 and day 2. Cohort 21, 22, 23, 24, and 25 will receive a dosage of up to 5000 mg of LEN via SC or IM, with an optional tablet loading oral dosage of 600 mg of LEN on Day 1 and Day 2. Cohort 26, 27, 28, 29, 30 and 31 will receive a dosage of up to 5000 mg of LE via SC or IM, with an optional tablet loading oral dosage of 600 mg of LEN on any or all of Days 1, 2, 8 and 15. The mode of administered to participants will be based on sponsor decision based on emerging data from previous cohorts. For the optional loading dose, the oral dosing of LEN tablet is sponsor decision based on emerging data from previous cohorts. Strategies used to monitor adherence to the intervention if applicable is, all doses are administered by clinic by research nurse.
Sponsors
Gilead Sciences
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
Have the ability to understand and sign a written informed consent form, Be aged 18 through 55 years, be a nonsmoker. The use of nicotine containing products must be discontinued 42 days prior to the administration of the study drug. Have a calculated body mass index not 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}), Participants 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. Must be willing and able to comply with all study requirements.
Exclusion criteria
Positive serum or urine pregnancy test, Breastfeeding female, Is currently participating in or has participated in an interventional clinical study with an investigational medicinal product within 30 days prior to study dosing on Day 1 through the duration of the study. Have current alcohol or substance abuse judged by the investigator, Assessed by the investigator as being at risk for HIV infection in the past 6 months, Have a positive test result for HIV at screening, Have a positive test result for hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibody at screening. Have taken any prescription medications or over-the-counter medications, including herbal products, within 28 days prior to start of study drug dosing, 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 drug, 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, Have any serious or active medical or psychiatric illness (including depression).
Outcome results
None listed