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Trial registered on ANZCTR


Registration number
ACTRN12623000535673
Ethics application status
Approved
Date submitted
21/04/2023
Date registered
19/05/2023
Date last updated
3/10/2023
Date data sharing statement initially provided
19/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
GS-US-200-5717: A Phase 1 Study in Healthy Participants to Evaluate the Safety,
Tolerability, and Pharmacokinetics of Subcutaneous and
Intramuscular Lenacapavir
Scientific title
GS-US-200-5717:A Phase 1 Study in Healthy Participants to Evaluate the Safety,
Tolerability, and Pharmacokinetics of Subcutaneous and
Intramuscular Lenacapavir
Secondary ID [1] 309231 0
GS-US-200-5717
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 329416 0
Condition category
Condition code
Infection 326360 326360 0 0
Acquired immune deficiency syndrome (AIDS / HIV)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 325695 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334215 0
Safety and tolerability assessed by physical exam, injection site examinations, patient report pain questionnaire, review of concomitant medications, vitals signs, clinical laboratories (hematology, chemistry, creatinine clearance calculation, and urinalysis), serum pregnancy tests, 12-lead ECG, Adverse events and laboratory toxicities will be assessed and managed according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric AEs, Version 2.1 dated July 2017.
Timepoint [1] 334215 0
These will be assessed daily through confinement (Day -1 through Discharge Day 15 post-intervention administration) and then Days 22, 29, 36, 43, 57, 71, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, 351, 365, 379 , 421, and 449 post-intervention administration. Telephone contacts will be conducted to review adverse events, and concomitant medications on Days 99, 127, 155, 183, 211, 239, 267, 295, 323, 407, and 435 post-intervention administration
Secondary outcome [1] 419863 0
Secondary Outcome: The following plasma PK parameters for LEN (and metabolites, if appropriate) will be calculated for each analyte, as applicable: AUCinf, AUClast, %AUCexp, Cmax, Tmax, Clast, Tlast, lambda z, CL/F, t1/2, and Vz/F
Timepoint [1] 419863 0
Day 1 : 0 ( Pre dose less than/equal to 5 minutes before dose) 2,4,8, and 12 hours post dose.
Day 2 : 24 and 36 hours post dose.
A single anytime PK sample will be collected on Days 3,4,6,8,10,15,22,29,36,43,57,71,85,113,141,169,197,225,253,281,309,337,351,365,379,393,421,449 post-dose.
.

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/10/2023
Actual
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
24/03/2025
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 25337 0
New Zealand
State/province [1] 25337 0
Country [2] 25338 0
United States of America
State/province [2] 25338 0

Funding & Sponsors
Funding source category [1] 313421 0
Commercial sector/Industry
Name [1] 313421 0
Gilead Sciences
Country [1] 313421 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Level 6, 417 St Kilda Road
Melbourne Vic 3004
Country
Australia
Secondary sponsor category [1] 315185 0
None
Name [1] 315185 0
Address [1] 315185 0
Country [1] 315185 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312634 0
Northern B Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 312634 0
Ministry of Health
133 Molesworth Street
Thorndon, Wellington, 6011
Ethics committee country [1] 312634 0
New Zealand
Date submitted for ethics approval [1] 312634 0
Approval date [1] 312634 0
02/05/2023
Ethics approval number [1] 312634 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125362 0
Dr Christian Schwabe
Address 125362 0
New Zealand Clinical Research
3 Ferncroft Street
Grafton, Auckland, 1010
Country 125362 0
New Zealand
Phone 125362 0
+6493733474
Fax 125362 0
+6493733479
Email 125362 0
[email protected]
Contact person for public queries
Name 125363 0
Christian Schwabe
Address 125363 0
New Zealand Clinical Research
3 Ferncroft Street
Grafton, Auckland, 1010
Country 125363 0
New Zealand
Phone 125363 0
+6493733474
Fax 125363 0
+6493733479
Email 125363 0
[email protected]
Contact person for scientific queries
Name 125364 0
Christian Schwabe
Address 125364 0
New Zealand Clinical Research
3 Ferncroft Street
Grafton, Auckland, 1010
Country 125364 0
New Zealand
Phone 125364 0
+6493733474
Fax 125364 0
+6493733479
Email 125364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Study is for supporting compound development only.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.