Healthy ParticipantsPhase 1NCT06205381
Assessment of the Safety, Tolerability and Pharmacokinetics of AV078 in Healthy Volunteers
A Phase 1 study testing AV078, Itraconazole and Midazolam in people with Healthy Participants, run by Aeovian Pharmaceuticals, Inc. at 2 sites in Australia.
Trial summary
This Phase 1 study in healthy adult volunteers is planned to evaluate the safety, tolerability, and pharmacokinetics (PK) of AV078, a selective inhibitor of mammalian target of rapamycin complex 1 (mTORC1). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- AV078, Itraconazole and Midazolam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 89 participants
- Where
- 2 sitesAustralia
- Study dates
- 31 Jan 2024to 8 Feb 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female as determined by medical evaluation including medical history, psychiatric history, and no clinically significant findings on physical examination, laboratory tests, and cardiac monitoring. Slight excursions outside of normal limits may be allowed provided they are considered not clinically significant by the investigator.
- Ages 18-65 years (inclusive), at the time of consent.
- At least 45 kg with a body mass index (BMI; Quetelet index) in the range 18.0-32.0, at screening.
- Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or their delegate.
- Agree not to donate blood or blood products during the study and for up to 3 months after the last administration of the trial medication.
- Have received at least 2 doses of the COVID vaccine (1 dose of the Janssen-Cilag vaccine is acceptable).
Who cannot join
- Current, or past history of any clinically significant mental or physical illness or condition that the Investigator concludes would create significant concern for participation in the study.
- Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines (cholecystectomy is allowed).
- Presence or history of severe adverse reaction to any drug or a history of sensitivity to midazolam (Part E only), fexofenadine (Part E only) and itraconazole (Part D only), or any excipients in the tablets/solutions.
- History of relevant atopy including any confirmed significant allergic reactions against any drug, or multiple drug allergies (non-active hay fever is acceptable)
- History of suicidal behaviour or express or have any suicidal ideation on the C-SSRS at screening or admission.
- Employee of the Sponsor, the CRO and/or study site or their relatives.
- Unable or unwilling to eat a high-fat breakfast per study requirements (Part C only).
Trial locations and contacts
2 sites in 1 country.
Australia2 sites
Q-Pharm
Herston, Queensland, 4006
Nucleus Network Pty Ltd
Melbourne, Victoria, 3220
About this study
Official title: A Phase 1, Single And Multiple Ascending Dose, Food Effect, and Drug-Drug Interaction Study With Itraconazole, Midazolam and Fexofenadine Of Orally Administered AV078 In Healthy Adults
This Phase 1 study in healthy adult volunteers is planned to evaluate the safety, tolerability, and pharmacokinetics (PK) of AV078, a selective inhibitor of mammalian target of rapamycin complex 1 (mTORC1).
The study will begin with a standard exploration of safety and tolerability in sequential single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Subsequent cohorts will collect PK data to evaluate food effects and potential drug-drug interactions relevant to AV078.
Read the detailed description
This Phase 1 study in healthy adult volunteers is planned to evaluate the safety, tolerability, and pharmacokinetics (PK) of AV078, a selective inhibitor of mammalian target of rapamycin complex 1 (mTORC1). The study will additionally explore the relationship between AV078 and pharmacodynamic biomarkers related to mTOR.
The study will begin with a standard exploration of safety and tolerability in sequential single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, incorporating reviews by a dedicated Safety Review Group to guide dose escalation decisions. The study will also include a cohort using a 2-way crossover design to evaluate food effects on the PK of AV078. The study will additionally include cohorts evaluating potential drug-drug-interactions (DDIs) using coadministration of index substrates and index perpetrators typically used in DDI studies of the relevant enzymes. Specifically, one DDI cohort will assess the effects of administration of itraconazole (a strong inhibitor of CYP3A4) on the PK of AV078, and an additional DDI cohort will assess the effects of administration of AV078 on the PK of midazolam (a sensitive probe substrate for CYP3A4) and fexofenadine (a probe substrate for P-gp).
- Conditions
- Healthy Participants
- Being tested
- AV078, Placebo, Itraconazole, Midazolam, Fexofenadine
- Keywords
- mTOR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AV078Drug
Oral solution containing active ingredient, AV078
PlaceboDrug
Oral solution with no active ingredients
ItraconazoleDrug
Once daily oral dose of 200 mg itraconazole administered for 9 days
MidazolamDrug
2.5 mg midazolam administered orally on day 1 and day 18
FexofenadineDrug
120 mg fexofenadine administered orally on day 1 and day 18
| Study group | Role | What they receive |
|---|---|---|
| AV078 | Experimental | In part A, a single ascending doses of AV078 oral solution will be investigated in separate cohorts. The starting dose will be 0.5 mg and ascending doses will be determined based on data from previous cohorts.
In Part B, multiple ascending doses of AV078 oral solution will be administered once daily for 14 days. Dose levels will be determined based on data from the single ascending dose study and previous cohorts in the multiple ascending dose study.
In Part C the effect of food (fasting or high calorie) on the pharmacokinetics of a single dose of AV078 will be investigated. The dose will be determined from Part A of the study. Receives: Drug: AV078 |
| Placebo | Placebo comparator | In Part A, placebo oral solution (containing no active ingredient) will be administered once.
In Part B, placebo oral solution (containing no active ingredient) will be administered once daily for 14 days. Receives: Drug: Placebo |
| Itraconazole | Other | In Part D, 200 mg itraconazole will be administered as an oral capsule once daily for 9 days, to investigate the effect of itraconazole on the pharmacokinetics of AV078. Receives: Drug: Itraconazole |
| Midazolam and fexofenadine | Other | In Part E, 2.5 mg midazolam will be administered as an oromucosal solution and 120 mg fexofenadine will be administered as an oral tablet on day 1 and day 18, to investigate the effect of AV078 on the pharmacokinetics of midazolam and fexofenadine. Receives: Drug: Midazolam; Drug: Fexofenadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment emergent adverse events (TEAEs).
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Occurrence of clinically significant changes in physical examination (including neurological assessment).
Abnormal physical examination findings will be listed.
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change in blood haematology values.
Haematology data will be summarised by treatment
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change in blood biochemisty values.
Biochemistry data will be summarised by treatment
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change in urinalysis values.
Urinalysis data will be summarised by treatment
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change in lipid panel values.
Lipid panel data will be summarised by treatment
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change in blood coagulation values.
Blood coagulation data will be summarised by treatment
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Clinically significant ECG findings.
Occurrence of clinically significant ECG findings will be listed.
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Monitor for the emergence of suicidal ideation and behaviour using the Columbia-Suicide Severity Rating Scale (C-SSRS).
C-SSRS will be listed and summarised for each visit.
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics measured by area under the concentration-time curve in fasted and fed state.
To determine the effect of food on the pharmacokinetic profile of AV078.
Measured: Day 1 to Day 7 post-dose and final follow-up visit (Day 14)
Pharmacokinetics measured by the maximum plasma concentration (Cmax) in fasted and fed state.
To determine the effect of food on the pharmacokinetic profile of AV078.
Measured: Day 1 to Day 7 post-dose and final follow-up visit (Day 14)
Effects of itraconazole on the pharmacokinetics of AV078 measured by area under the concentration-time curve.
Measured: Day 1 to Day 15 post-dose and final follow-up visit (Day 23)
Effects of itraconazole on the pharmacokinetics of AV078 measured by the maximum plasma concentration (Cmax).
Measured: Day 1 to Day 15 post-dose and final follow-up visit (Day 23)
Effects of AV078 on the pharmacokinetics of midazolam and fexofenadine measured by area under the concentration-time curve.
Measured: Day 1, 2, 18 and 19 post-dose (midazolam) or Day 1-3, 18 and 19 post-dose (fexofenadine)
Effects of AV078 on the pharmacokinetics of midazolam and fexofenadine measured by the maximum plasma concentration (Cmax).
Measured: Day 1, 2, 18 and 19 post-dose (midazolam) or Day 1-3, 18 and 19 post-dose (fexofenadine)
Secondary outcomes (18)
Pharmacokinetics of AV078 measured by the area under the concentration-time curve.
Measured: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics of AV078 measured by the maximum plasma concentration (Cmax).
Measured: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics of AV078 measured by time of maximum plasma/whole blood concentration.
Measured: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics of AV078 measured by terminal elimination half-life.
Measured: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics of AV078 measured by fraction of drug excreted in urine.
Measured: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics of AV078 measured by renal clearance from plasma/whole blood.
Measured: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change from baseline and placebo-corrected change from baseline in ECG parameter, QTcF including exposure response.
Measured: Part A: Screening (Day -42) to Day 5 post-dose, and final follow-up visit (Day 14). Part B: Screening (Day -42) to Day 2 post-dose, then Day 4, 7, 10, 14, 15 and 18 post-dose, and final follow-up visit (Day 42)]
Change from baseline and placebo-corrected change from baseline in ECG parameter - heart rate (HR)
ECG parameters will be descriptively summarised at each time point.
Measured: Part A: Screening (Day -42) to Day 5 post-dose, and final follow-up visit (Day 14). Part B: Screening (Day -42) to Day 2 post-dose, then Day 4, 7, 10, 14, 15 and 18 post-dose, and final follow-up visit (Day 42)]
Change from baseline and placebo-corrected change from baseline in ECG parameter - PR interval
ECG parameters will be descriptively summarised at each time point.
Measured: Part A: Screening (Day -42) to Day 5 post-dose, and final follow-up visit (Day 14). Part B: Screening (Day -42) to Day 2 post-dose, then Day 4, 7, 10, 14, 15 and 18 post-dose, and final follow-up visit (Day 42)]
Change from baseline and placebo-corrected change from baseline in ECG parameter - QRS interval
ECG parameters will be descriptively summarised at each time point.
Measured: Part A: Screening (Day -42) to Day 5 post-dose, and final follow-up visit (Day 14). Part B: Screening (Day -42) to Day 2 post-dose, then Day 4, 7, 10, 14, 15 and 18 post-dose, and final follow-up visit (Day 42)]
Incidence and severity of treatment emergent adverse events (TEAEs)
Assessed for single doses of AV078 taken fasted or after a high-fat breakfast and repeated oral doses of AV078
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Occurrence of clinically significant changes in physical examination (including neurological assessment).
Abnormal physical examination findings will be listed.
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Change in blood haematology values
Haematology data will be summarised by treatment.
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Change in blood biochemistry values
Biochemistry data will be summarised by treatment.
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Change in urinalysis values
Urinalysis data will be summarised by treatment.
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Change in lipid panel values
Lipid panel data will be summarised by treatment.
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Change in blood coagulation values
Coagulation data will be summarised by treatment.
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Monitor for the emergence of suicidal ideation and behaviour using the Columbia-Suicide Severity Rating Scale (C-SSRS)
C-SSRS will be listed and summarised for each visit
Measured: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start31 Jan 2024
- Primary completion8 Feb 2025
- Study completion8 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A will study single doses of AV078 in a double-blind randomized, placebo-controlled, parallel-group and dose-escalating design ("single ascending dose \[SAD\] study"). Part B will study repeated doses of AV078 (once daily for 14 days) in a double-blind, randomized, placebo-controlled, parallel-group and dose-escalating design ("multiple ascending dose \[MAD\] study"). Part C will study the effect of food on the PK of AV078 in an open-label, randomized sequence 2-way crossover design. Part D will study the effect of itraconazole on the PK of AV078 in an open-label, fixed sequence design. Part E will study the effect of AV078 on the PK of midazolam and fexofenadine in an open-label, fixed sequence design.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aeovian Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Davis Ryman, Study director, Chief Medical Officer, Aeovian Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06205381
- Sponsor's protocol ID
- CL-078-101
- Status last verified
- Mar 2024
- First submitted
- 19 Dec 2023
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single And Multiple Ascending Dose, Food Effect, and Drug-Drug Interaction Study With Itraconazole, Midazolam and Fexofenadine Of Orally Administered AV078 In Healthy Adults
- ClinicalTrials.gov ID
- NCT06205381
- Acronym / sponsor ID
- CL-078-101
- Conditions
- Healthy Participants
- Keywords
- mTOR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Aeovian Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 8 Feb 2025 (actual)
- Study completion
- 8 Feb 2025 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This Phase 1 study in healthy adult volunteers is planned to evaluate the safety, tolerability, and pharmacokinetics (PK) of AV078, a selective inhibitor of mammalian target of rapamycin complex 1 (mTORC1).
The study will begin with a standard exploration of safety and tolerability in sequential single ascending dose (SAD) and multiple ascending dose (MAD) cohorts. Subsequent cohorts will collect PK data to evaluate food effects and potential drug-drug interactions relevant to AV078.
Detailed description
This Phase 1 study in healthy adult volunteers is planned to evaluate the safety, tolerability, and pharmacokinetics (PK) of AV078, a selective inhibitor of mammalian target of rapamycin complex 1 (mTORC1). The study will additionally explore the relationship between AV078 and pharmacodynamic biomarkers related to mTOR.
The study will begin with a standard exploration of safety and tolerability in sequential single ascending dose (SAD) and multiple ascending dose (MAD) cohorts, incorporating reviews by a dedicated Safety Review Group to guide dose escalation decisions. The study will also include a cohort using a 2-way crossover design to evaluate food effects on the PK of AV078. The study will additionally include cohorts evaluating potential drug-drug-interactions (DDIs) using coadministration of index substrates and index perpetrators typically used in DDI studies of the relevant enzymes. Specifically, one DDI cohort will assess the effects of administration of itraconazole (a strong inhibitor of CYP3A4) on the PK of AV078, and an additional DDI cohort will assess the effects of administration of AV078 on the PK of midazolam (a sensitive probe substrate for CYP3A4) and fexofenadine (a probe substrate for P-gp).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Part A will study single doses of AV078 in a double-blind randomized, placebo-controlled, parallel-group and dose-escalating design ("single ascending dose [SAD] study"). Part B will study repeated doses of AV078 (once daily for 14 days) in a double-blind, randomized, placebo-controlled, parallel-group and dose-escalating design ("multiple ascending dose [MAD] study"). Part C will study the effect of food on the PK of AV078 in an open-label, randomized sequence 2-way crossover design. Part D will study the effect of itraconazole on the PK of AV078 in an open-label, fixed sequence design. Part E will study the effect of AV078 on the PK of midazolam and fexofenadine in an open-label, fixed sequence design.
| Arm | Type | Receives |
|---|---|---|
| AV078 | Experimental | Drug: AV078In part A, a single ascending doses of AV078 oral solution will be investigated in separate cohorts. The starting dose will be 0.5 mg and ascending doses will be determined based on data from previous cohorts. In Part B, multiple ascending doses of AV078 oral solution will be administered once daily for 14 days. Dose levels will be determined based on data from the single ascending dose study and previous cohorts in the multiple ascending dose study. In Part C the effect of food (fasting or high calorie) on the pharmacokinetics of a single dose of AV078 will be investigated. The dose will be determined from Part A of the study. |
| Placebo | Placebo comparator | Drug: PlaceboIn Part A, placebo oral solution (containing no active ingredient) will be administered once. In Part B, placebo oral solution (containing no active ingredient) will be administered once daily for 14 days. |
| Itraconazole | Other | Drug: ItraconazoleIn Part D, 200 mg itraconazole will be administered as an oral capsule once daily for 9 days, to investigate the effect of itraconazole on the pharmacokinetics of AV078. |
| Midazolam and fexofenadine | Other | Drug: Midazolam, Drug: FexofenadineIn Part E, 2.5 mg midazolam will be administered as an oromucosal solution and 120 mg fexofenadine will be administered as an oral tablet on day 1 and day 18, to investigate the effect of AV078 on the pharmacokinetics of midazolam and fexofenadine. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Healthy male or female as determined by medical evaluation including medical history, psychiatric history, and no clinically significant findings on physical examination, laboratory tests, and cardiac monitoring. Slight excursions outside of normal limits may be allowed provided they are considered not clinically significant by the investigator.
- Ages 18-65 years (inclusive), at the time of consent.
- At least 45 kg with a body mass index (BMI; Quetelet index) in the range 18.0-32.0, at screening.
- Sufficient intelligence to understand the nature of the trial and any hazards of participating in it. Ability to communicate satisfactorily with the investigator and to participate in, and comply with the requirements of, the entire trial.
- Willingness to give written consent to participate after reading the information and consent form, and after having the opportunity to discuss the trial with the investigator or their delegate.
Key exclusion criteria (7 listed)
- Current, or past history of any clinically significant mental or physical illness or condition that the Investigator concludes would create significant concern for participation in the study.
- Surgery (eg stomach bypass) or medical condition that might affect absorption of medicines (cholecystectomy is allowed).
- Presence or history of severe adverse reaction to any drug or a history of sensitivity to midazolam (Part E only), fexofenadine (Part E only) and itraconazole (Part D only), or any excipients in the tablets/solutions.
- History of relevant atopy including any confirmed significant allergic reactions against any drug, or multiple drug allergies (non-active hay fever is acceptable)
- History of suicidal behaviour or express or have any suicidal ideation on the C-SSRS at screening or admission.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AV078Oral solution containing active ingredient, AV078 | Drug | AV078 |
| PlaceboOral solution with no active ingredients | Drug | Placebo |
| ItraconazoleOnce daily oral dose of 200 mg itraconazole administered for 9 days | Drug | Itraconazole |
| Midazolam2.5 mg midazolam administered orally on day 1 and day 18 | Drug | Midazolam and fexofenadine |
| Fexofenadine120 mg fexofenadine administered orally on day 1 and day 18 | Drug | Midazolam and fexofenadine |
Primary outcome
Incidence and severity of treatment emergent adverse events (TEAEs).
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Occurrence of clinically significant changes in physical examination (including neurological assessment).
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Abnormal physical examination findings will be listed.
Change in blood haematology values.
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Haematology data will be summarised by treatment
Change in blood biochemisty values.
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Biochemistry data will be summarised by treatment
Change in urinalysis values.
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Urinalysis data will be summarised by treatment
Change in lipid panel values.
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Lipid panel data will be summarised by treatment
Change in blood coagulation values.
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Blood coagulation data will be summarised by treatment
Clinically significant ECG findings.
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Occurrence of clinically significant ECG findings will be listed.
Monitor for the emergence of suicidal ideation and behaviour using the Columbia-Suicide Severity Rating Scale (C-SSRS).
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
C-SSRS will be listed and summarised for each visit.
Pharmacokinetics measured by area under the concentration-time curve in fasted and fed state.
Time frame: Day 1 to Day 7 post-dose and final follow-up visit (Day 14)
To determine the effect of food on the pharmacokinetic profile of AV078.
Pharmacokinetics measured by the maximum plasma concentration (Cmax) in fasted and fed state.
Time frame: Day 1 to Day 7 post-dose and final follow-up visit (Day 14)
To determine the effect of food on the pharmacokinetic profile of AV078.
Effects of itraconazole on the pharmacokinetics of AV078 measured by area under the concentration-time curve.
Time frame: Day 1 to Day 15 post-dose and final follow-up visit (Day 23)
Effects of itraconazole on the pharmacokinetics of AV078 measured by the maximum plasma concentration (Cmax).
Time frame: Day 1 to Day 15 post-dose and final follow-up visit (Day 23)
Effects of AV078 on the pharmacokinetics of midazolam and fexofenadine measured by area under the concentration-time curve.
Time frame: Day 1, 2, 18 and 19 post-dose (midazolam) or Day 1-3, 18 and 19 post-dose (fexofenadine)
Effects of AV078 on the pharmacokinetics of midazolam and fexofenadine measured by the maximum plasma concentration (Cmax).
Time frame: Day 1, 2, 18 and 19 post-dose (midazolam) or Day 1-3, 18 and 19 post-dose (fexofenadine)
18 secondary outcomes
Pharmacokinetics of AV078 measured by the area under the concentration-time curve.
Time frame: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics of AV078 measured by the maximum plasma concentration (Cmax).
Time frame: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics of AV078 measured by time of maximum plasma/whole blood concentration.
Time frame: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics of AV078 measured by terminal elimination half-life.
Time frame: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics of AV078 measured by fraction of drug excreted in urine.
Time frame: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Pharmacokinetics of AV078 measured by renal clearance from plasma/whole blood.
Time frame: Day 1 to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).
Change from baseline and placebo-corrected change from baseline in ECG parameter, QTcF including exposure response.
Time frame: Part A: Screening (Day -42) to Day 5 post-dose, and final follow-up visit (Day 14). Part B: Screening (Day -42) to Day 2 post-dose, then Day 4, 7, 10, 14, 15 and 18 post-dose, and final follow-up visit (Day 42)]
Change from baseline and placebo-corrected change from baseline in ECG parameter - heart rate (HR)
Time frame: Part A: Screening (Day -42) to Day 5 post-dose, and final follow-up visit (Day 14). Part B: Screening (Day -42) to Day 2 post-dose, then Day 4, 7, 10, 14, 15 and 18 post-dose, and final follow-up visit (Day 42)]
Change from baseline and placebo-corrected change from baseline in ECG parameter - PR interval
Time frame: Part A: Screening (Day -42) to Day 5 post-dose, and final follow-up visit (Day 14). Part B: Screening (Day -42) to Day 2 post-dose, then Day 4, 7, 10, 14, 15 and 18 post-dose, and final follow-up visit (Day 42)]
Change from baseline and placebo-corrected change from baseline in ECG parameter - QRS interval
Time frame: Part A: Screening (Day -42) to Day 5 post-dose, and final follow-up visit (Day 14). Part B: Screening (Day -42) to Day 2 post-dose, then Day 4, 7, 10, 14, 15 and 18 post-dose, and final follow-up visit (Day 42)]
Incidence and severity of treatment emergent adverse events (TEAEs)
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Occurrence of clinically significant changes in physical examination (including neurological assessment).
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Change in blood haematology values
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Change in blood biochemistry values
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Change in urinalysis values
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Change in lipid panel values
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Change in blood coagulation values
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Monitor for the emergence of suicidal ideation and behaviour using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part C, Day 23 for Part D and Day 26 for Part E)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Davis Ryman study director
Chief Medical Officer, Aeovian Pharmaceuticals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AV078, Itraconazole and Midazolam in people with Healthy Participants, run by Aeovian Pharmaceuticals, Inc. at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment emergent adverse events (TEAEs). (time frame: From screening (Day -42) to final visit post-treatment (Day 14 for Part A and Day 42 for Part B).). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2025.