A Phase 1 interventional study of AV078 and Placebo in Healthy Participants, sponsored by Aeovian Pharmaceuticals, Inc.. Completed at 2 sites in Australia. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-26.
Sponsored by Aeovian Pharmaceuticals, Inc. · Phase 1, Interventional, and Treatment
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.
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).
Aeovian Pharmaceuticals, Inc. is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: AV078
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.
Drug: Placebo
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.
Drug: Itraconazole
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.
Drug: Midazolam · Drug: Fexofenadine
Oral solution containing active ingredient, AV078
Oral solution with no active ingredients
Once daily oral dose of 200 mg itraconazole administered for 9 days
2.5 mg midazolam administered orally on day 1 and day 18
120 mg fexofenadine administered orally on day 1 and day 18
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).
Abnormal physical examination findings will be listed.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
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)
ECG parameters will be descriptively summarised at each time point.
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
ECG parameters will be descriptively summarised at each time point.
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
ECG parameters will be descriptively summarised at each time point.
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)
Assessed for single doses of AV078 taken fasted or after a high-fat breakfast and repeated oral doses of AV078
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).
Abnormal physical examination findings will be listed.
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
Haematology data will be summarised by treatment.
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
Biochemistry data will be summarised by treatment.
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
Urinalysis data will be summarised by treatment.
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
Lipid panel data will be summarised by treatment.
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
Coagulation data will be summarised by treatment.
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)
C-SSRS will be listed and summarised for each visit
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)
Plan to share: No
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This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Fexofenadine
Aeovian Pharmaceuticals, Inc.