Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000536662
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-200-5710: A Phase 1 Study in Healthy Participants to Evaluate the Safety,
Tolerability, and Pharmacokinetics of Subcutaneous and
Intramuscular Lenacapavir
Scientific title
GS-US-200-5710: A Phase 1 Study in Healthy Participants to Evaluate the Safety,
Tolerability, and Pharmacokinetics of Subcutaneous and
Intramuscular Lenacapavir
Secondary ID [1] 309248 0
GS-US-200-5710
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
HIV 329406 0
Condition category
Condition code
Infection 326352 326352 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 formulations and dose level of Lenacapavir will vary between cohorts with or without an Optional 600 mg loading oral dose of Lenacapavir and/ or optional pretreatment/coadministration of up to 600 units/injection recombinant human hyaluronidase on Day 1 and Day 2 based on emerging data from previous cohorts.

Cohort 1 will receive a dose of 1200 mg SC LEN on Day 1
Cohort 2 will receive a dose of up to 1200 mg SC LEN on Day 1, with an optional tablet loading oral dosage of 600 mg of LEN on Day 1 and Day 2
Cohort 3 will receive a dose of up to 1200 mg SC LEN on Day 1

Cohort 4 will receive a dose of 100 mg SC LEN on Day 1
Cohort 5 will receive a dose of up to 300 mg SC LEN on Day 1, with an optional tablet loading oral dosage of 600 mg of LEN on Day 1 and Day 2
Cohort 6 will receive a dose of up to 800 mg SC LEN on Day 1, with an optional tablet loading oral dosage of 600 mg of LEN on Day 1 and Day 2

Cohort 7 will receive a dose of 125 mg SC LEN on Day 1
Cohort 8 will receive a dose of up to 375 mg SC LEN on Day 1, with an optional tablet loading oral dosage of 600 mg of LEN on Day 1 and Day 2
Cohort 9 will receive a dose of up to 1000 mg SC LEN on Day 1, with an optional tablet loading oral dosage of 600 mg of LEN on Day 1 and Day 2

Cohort 10 will receive a dose of 150 mg SC LEN on Day 1
Cohort 11 will receive a dose of up to 450 mg SC LEN on Day 1, with an optional tablet loading oral dosage of 600 mg of LEN on Day 1 and Day 2
Cohort 12 will receive a dose of up to 1200 mg SC LEN on Day 1, with an optional tablet loading oral dosage of 600 mg of LEN on Day 1 and Day 2

Cohort 13 will receive an oral tablet loading dose of 600 mg LEN with up to 600 mg SC LEN on Day 1. And oral tablet loading dose of 600 mg LEN ill be given on Day 2

Cohort 14 and 15 will receive up to 5000 mg IM LEN on Day 1, with an optional tablet loading oral dosage of 600 mg of LEN on Day 1 and Day 2

Cohorts 22, 23, 24, 25 ,26 ,27 ,28 ,29, 30 and 31 will receive up to 5000 mg SC or IM LEN, with an optional tablet loading oral dosage of 600 mg of LEN and/ or optional pretreatment/coadministration of up to 600 units/injection recombinant human hyaluronidase on Day 1 and Day 2

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. For the optional pretreatment/coadministration of recombinant human hyaluronidase, the dosing of units/ injection 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] 325690 0
Treatment: Drugs
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334210 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] 334210 0
These will be assessed daily through confinement (Day -1 through Discharge Day 15) and then Days 22, 29, 31, 36, 43, 57, 61, 71, 85, 91a, 113, 141, 169, 183, 197, 225, and 253 post-intervention administration. Telephone contacts will be conducted to review adverse events, and concomitant medications on Days 127, 155, 211, and 239 post-intervention administration
Secondary outcome [1] 419840 0
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] 419840 0
Day 1: 0 (pre-dose; less than or 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, 31a, 36, 43, 57, 61a, 71, 85, 91a, 113, 141, 169,
183a, 197, 225, and 253 post-dose.
(A Days 31, 61, 91, and 183 are not applicable to Cohorts 1, 3, 4, 7, 10, and 13 post-dose.)

Eligibility
Key inclusion criteria
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.
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 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
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
31/05/2024
Actual
Date of last data collection
Anticipated
24/09/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 25333 0
New Zealand
State/province [1] 25333 0
Country [2] 25334 0
United States of America
State/province [2] 25334 0

Funding & Sponsors
Funding source category [1] 313440 0
Commercial sector/Industry
Name [1] 313440 0
Gilead Sciences
Country [1] 313440 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] 315210 0
None
Name [1] 315210 0
Address [1] 315210 0
Country [1] 315210 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312646 0
Northern B Health and Disability Ethics Committees (HDEC)
Ethics committee address [1] 312646 0
Ethics committee country [1] 312646 0
New Zealand
Date submitted for ethics approval [1] 312646 0
Approval date [1] 312646 0
02/05/2023
Ethics approval number [1] 312646 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125410 0
Dr Christian Schwabe
Address 125410 0
New Zealand Clinical Research
3 Ferncroft Street
Grafton, Auckland. 1010
Country 125410 0
New Zealand
Phone 125410 0
+6493733474
Fax 125410 0
+6493733479
Email 125410 0
[email protected]
Contact person for public queries
Name 125411 0
Christian Schwabe
Address 125411 0
New Zealand Clinical Research
3 Ferncroft Street
Grafton, Auckland. 1010
Country 125411 0
New Zealand
Phone 125411 0
+6493733474
Fax 125411 0
+6493733479
Email 125411 0
[email protected]
Contact person for scientific queries
Name 125412 0
Christian Schwabe
Address 125412 0
New Zealand Clinical Research
3 Ferncroft Street
Grafton, Auckland. 1010
Country 125412 0
New Zealand
Phone 125412 0
+6493733474
Fax 125412 0
+6493733479
Email 125412 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.