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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001074381
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
28/07/2026
Date registered
Help: Date registered
31/08/2026
Date last updated
Help: Date last updated
31/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
31/08/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
A Phase 1, Open Label, non-randomised Drug-Drug interaction (DDI) for GV-100 (Part 4)
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study of Single and Multiple Ascending Doses of GV-100 with Food-Effect and Drug-Drug Interaction Evaluations in Healthy Participants (Drug-Drug Interaction - Part4)
Additional trial identifiers [1] 317624 0
GV-GV100-CT01
Universal Trial Number (UTN)
Trial acronym
Related trial records
ACTRN12626000762358 describes part 1 and 2 of this 4-part study and this is part 4

Health condition
Health condition(s) studied:
Autosomal Dominant Polycystic Kidney Disease (ADPKD) 342402 0
Condition category
Condition code
Renal and Urogenital 338535 338535 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The Drug-drug Interaction part will evaluate the effect of GV-100 on cytochrome (CYP) 3A4 and cytochrome (CYP) 2B6 activity and may be initiated after Safety Review Committee (SRC) approval of safety, tolerability, and Pharmacokinetic (PK) data from multiple ascending dose (MAD) Cohort 3. The GV-100 dose will be selected based on cumulative safety and Pharmacokinetic (PK) data.

Approximately 12 participants will be enrolled in a fixed-sequence, non-randomized, open-label design. Probe substrates will include midazolam 1 mg (cytochrome (CYP) 3A4 substrate) and bupropion 75milligram (cytochrome (CYP) 2B6 substrate), both administered orally. Participants will be screened between Day -28 and Day -2, admitted on Day -1, confined through Day 15, and return for follow-up on Day19 (±1 day).

Participants will be administered a single oral dose of 1 mg midazolam, immediately followed by a single oral dose of 75 mg bupropion on Day 1. On Day 11, the participants will be administered a single oral dose of 1 mg midazolam, immediately followed by a single oral dose of 75 mg bupropion, immediately followed by a single oral dose of GV-100.

Participants will be admitted to hospital as inpatient and the administration for the selected dose of GV-100QD for 7 consecutive days from Days 6 to 12.

A mouth check will be performed following administration to confirm complete consumption of the IP.
Intervention code [1] 334452 0
Treatment: Drugs
Description of the comparator or control
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 345813 0
Safety and tolerability will be assessed comparatively as a composite outcome.
Timepoint [1] 345813 0
Part 4: Drug-Drug Interaction (DDI) Vital Signs: At screening, on Day -1, on Day 1 prior to midazolam dosing and 1, 3, and24 (Day 2) hours post-bupropion-dose, on Days 6, 7, 8, 9, and 10 prior to GV-100 dosing, on Day 11 prior tomidazolam dosing and 1, 3, and 24 (prior to GV-100 dosing on Day 12) hours post-GV-100-dose, on Day 15prior to discharge, and at follow-up (or End of Treatment (Day19)). Safety Laboratory Test: At screening, on Day -1, at 24 hours post-bupropion dose (Day 2), on Days 6,8, 10, and 12 prior to GV-100 dosing, on Day 15 prior to discharge, and atfollow-up (or End of Treatment (Day19)). 12Lead Electrocardiogram (ECG): at screening, on Day -1, on Day 1 prior to midazolam dosing, on Day 6 prior to GV-100 dosing and 4, 12, and 24 (prior to GV-100 dosing on Day 7) hours post-dose, on Days 8, 9, and 10prior to GV-100 dosing, on Day 11 prior to midazolam dosing and 4, 12, and 24 (prior to GV-100 dosing on Day 12) hours post-GV-100 dosing, on Day 15 prior to discharge, and at follow-up (or End of Treatment (Day19)). Adverse Event: From screening to follow up /End of Study/End of Treatment (Day19).
Secondary outcome [1] 463408 0
Plasma PK parameters of GV-100, midazolam, 1-hydroxymidazolam, bupropion, 6-hydroxybupropion including, but not limited to: area under the concentration-time curve from time zero until the last observed concentration (AUClast), AUC0-inf, maximal observed concentration (Cmax), and terminal elimination half-life (T½). This will be assessed comparatively as a composite outcome
Timepoint [1] 463408 0
Bupropion PK Blood Samples Day 1: Pre-Dose (Within 30 minutes prior to midazolam dosing), 0.5 hours, 1hours, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours, Day2: 24 hours, Day 3 : 48 hours, Day 4: 72 hours, Day5: 96 hours, Day 11: Pre-dose (Within 30 minutes prior to midazolam dosing), 0.5 hours, 1 hours, 2 hours, 4hours, 6, hours, 8 hours, 12 hours, Day 12: 24hours, Day 13: 48 hours, Day 14: 72 hours and Day 15: 96 hours Midazolam PK Blood Samples Day1: Pre -Dose (Within 30 minutes prior to midazolam dosing), 0.5 hours, 1hours, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours, Day2: 24 hours, Day 11: Pre -Dose (Within 30 minutes prior to midazolam dosing), 0.5 hours, 1 hours, 2 hours, 4 hours, 6 hours, 8 hours and 12 hours Day 12:24Hours. PK Analysis of GV-100: Day6: Pre-dose (within 30min prior to GV-100 dosing), 0.5 hours, 1 hours, 2 hours, 4hours, 6, hours, 8 hours, 12 hours, Day7: 24Hours (Within 30 minutes prior to GV-100 dosing) Day 8-Day10: Pre-dose (Within 30 minutes prior to GV-100 dosing) Day11: Pre-dose Within 30 minutes prior to midazolam dosing ), 0.5 hours, 1 hours, 2 hours, 4hours, 6, hours, 8 hours, 12 hours, Day12: 24Hours (Within 30 minutes prior to GV-100 dosing) The outcomes above are composite outcomes.

Eligibility
Key inclusion criteria
- Male or female participants, aged more than or equal 18 to less than or equal to 65 years at the time of providing informed consent, who are non-smokers (no use of tobacco or nicotine-containing products within 3 months prior to screening), with a body mass index (BMI) greater than 18.0 and less than 32.0kilogram/meter square, and a minimum body weight of 50.0 kilogram.

- Healthy individuals, as determined by the Principal Investigator or delegate, defined as:
a. No clinically significant illness or surgical procedures within 4 weeks prior to study drug administration.
b. No clinically significant history of neurological, endocrine, cardiovascular, respiratory, hematological, immunological, psychiatric, gastrointestinal, renal, hepatic, or metabolic disorders.

- Capable of understanding the study procedures and willing to provide written informed consent prior to participation.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
- Any clinically significant abnormal finding on physical examination, as determined by the PrincipalInvestigator or delegate.
- Clinically significant abnormal laboratory results at screening, in the opinion of the Principal Investigatoror delegate.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and/or total bilirubin levels greaterthan 1.5 × the upper limit of normal (ULN) at screening.
- Estimated glomerular filtration rate (eGFR) Less than or equal 90 milliliter/minute/1.73 meter square atscreening, calculated using the CKD-EPI equation.
- Positive test results at screening for hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), hepatitis C virus (HCV) antibody, or human immunodeficiency virus (HIV) antigen or antibody. Participants with a positive hepatitis B surface antibody (HBsAb) due to prior vaccination are permitted.
- Any current active infection, including localized infections, or a recent history (within 1 week prior to dosing) of infection, cough, or fever, or a history of recurrent or chronic infections.
- Any disease or history of surgery that, in the opinion of the Principal Investigator or delegate, couldsignificantly affect the absorption, distribution, metabolism, or excretion of the investigational product.
- Positive pregnancy test or lactation in female participants.
- Positive urine drug screen, urine cotinine test, or alcohol breath test.
- History of clinically significant allergic reactions, including anaphylaxis, hypersensitivity, or angioedema,to any medication, or known allergy to GV-100, related compounds, or any formulation excipients.
- Clinically significant abnormalities in Electrocardiogram findings or vital signs at screening, as determined by the Principal Investigator or delegate.
- Supine systolic blood pressure greater than or equal to 160 mmHg or diastolic blood pressure greater than or equal to 95 millimeters of mercury. (mmHg) at screening after at least 5 minutes of rest. If elevated, blood pressure will be repeated two additional times, and the average of three measurements will be used to assess eligibility.
- History of drug abuse within 6 months prior to first dosing, or substance abuse considered clinically significant by the Principal Investigator or delegate.
- History of alcohol abuse within 6 months prior to first dosing, defined as consumption exceeding 21 units per week for males or 14 units per week for females
(1 unit equals 240 milliliter beer, 120 milliliter wine, or 30 milliliter distilled Alcohol).
- Use of depot injections or implants within 3 months prior to first dosing.
- Receipt of live or live-attenuated vaccines (bacterial or viral) within 12 weeks prior to screening, orplanned receipt during the study period.
- Receipt of any vaccine, including COVID-19 vaccines, within 14 days prior to first dosing.
- Use of any drug known to induce or inhibit hepatic drug-metabolizing enzymes within 30 days or 5 half-lives (whichever is longer) prior to first dosing.
- Use of prescription medications within 14 days or 5 half-lives (whichever is longer) prior to first dosing.
- Use of over-the-counter medications or natural health products, including herbal remedies (e.g., St.John’s wort), traditional medicines, probiotics, dietary supplements, or sports supplements within 14 daysor 5 half-lives (whichever is longer) prior to first dosing, except for occasional paracetamol up to2grams/day.
- Participation in another clinical research study involving an investigational or marketed drug ordevicewithin 30 days or 5 half-lives (whichever is longer) prior to first dosing; participation involving abiologicalproduct within 90 days prior to dosing; or concurrent participation in any investigational studywithout drugor device administration.
- Donation of plasma or platelets within 14 days prior to dosing, or donation or loss of equals 500 milliliterofwhole blood within 60 days prior to dosing.
- Previous exposure to GV-100.
- Any other condition or circumstance that, in the opinion of the Principal Investigator or delegate, could interfere with study participation or compliance, which will be documented in the source records.
- Psychiatric condition including recent (within the past year) or active
suicidal ideation/behavior or Columbia Suicidality Severity Rating
Scale (C-SSRS) score above Type 1 ideation.
- Use of monoamine oxidase inhibitors (MAOIs) (e.g., isocarboxazid,
phenelzine, tranylcypromine, moclobemide) for 30 days (or 5 half-lives,
whichever is longer) prior to first dosing.
- History of glaucoma.
- History of significant respiratory depression, airway obstruction, oxygen
desaturation, or apnea.
- History of anorexia nervosa or bulimia.
- History of seizure disorders.
- History of anaphylactoid/anaphylactic reactions or Stevens-Johnson
syndrome.
- Any known allergic reactions to midazolam or other related drugs, or to
any excipient in the formulation including allergies to cherries.
- Any known allergic reactions to bupropion or other related drugs, or to
any excipient in the formulation.

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
Open (masking not used)
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
12/01/2027
Actual
Date of last participant enrolment
Anticipated
20/01/2027
Actual
Date of last data collection
Anticipated
8/02/2027
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 322167 0
Commercial sector/Industry
Name [1] 322167 0
Gilva Therapeutics, INC.
Country [1] 322167 0
Taiwan, Province Of China
Primary sponsor type
Commercial sector/Industry
Name
Gilva Therapeutics, INC.
Address
Country
Taiwan, Province Of China
Secondary sponsor category [1] 325067 0
Commercial sector/Industry
Name [1] 325067 0
Novotech (Australia) Pty Limited
Address [1] 325067 0
Country [1] 325067 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320700 0
Bellberry Human Research Ethics Committee D
Ethics committee address [1] 320700 0
Ethics committee country [1] 320700 0
Australia
Date submitted for ethics approval [1] 320700 0
25/03/2026
Approval date [1] 320700 0
01/05/2026
Ethics approval number [1] 320700 0

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

Contacts
Principal investigator
Name 151326 0
Dr Jonathan Newchurch
Address 151326 0
CMAX Clinical Research, 21-24 North Terrace, Adelaide, SA 5000, Australia
Country 151326 0
Australia
Phone 151326 0
+61423223756
Fax 151326 0
Email 151326 0
[email protected]
Contact person for public queries
Name 151327 0
Jonathan Newchurch
Address 151327 0
CMAX Clinical Research, 21-24 North Terrace, Adelaide, SA 5000, Australia
Country 151327 0
Australia
Phone 151327 0
+61423223756
Fax 151327 0
Email 151327 0
[email protected]
Contact person for scientific queries
Name 151328 0
Jonathan Newchurch
Address 151328 0
CMAX Clinical Research, 21-24 North Terrace, Adelaide, SA 5000, Australia
Country 151328 0
Australia
Phone 151328 0
+61423223756
Fax 151328 0
Email 151328 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.