A Study to Assess the Effect of Acid-Reducing Medicines on ATH434 in Healthy Volunteers
A Phase 1 Drug-Drug Interaction Study to Assess the Effect of Esomeprazole (Acid Reducing Agent) on the Pharmacokinetics of ATH434 in Healthy Subjects
Alterity Therapeutics Limited
12 participants
Mar 13, 2026
Interventional
Conditions
Summary
This Phase 1 study evaluates the effect of esomeprazole (proton pump inhibitor), on the PK and safety of ATH434 in healthy volunteers. The primary hypothesis is that co-administration of esomeprazole will not significantly change the systemic exposure of a single 75 mg dose of ATH434. The study also aims to confirm the safety and tolerability of combining these treatments, using a fixed-sequence crossover design to compare ATH434 levels with and without esomeprazole.
Eligibility
Inclusion Criteria8
- Demographics: Male or female aged 18 to 55
- Health Status: - Good general health (normal physical, ECG, and labs).
- BMI: Between 18 and 32 kg/m².
- Contraception:
- Women must be postmenopausal, surgically sterile, or using double contraception.
- Men must use condoms or have a sterile partner (vasectomy/postmenopausal)
- Lifestyle: Willing to eat standardized meals and abstain from caffeine (48 hours pre-dose until discharge).
- Veins: Good venous access for blood draws.
Exclusion Criteria12
- Medical History:
- No significant history of heart, liver, kidney, GI, or neurologic disease.
- No conditions or surgeries that affect drug absorption (e.g., gastric bypass, chronic diarrhea).
- No history of significant drug allergies.
- Prohibited Substances:
- Nicotine: No tobacco/nicotine use in the last 3 months.
- Alcohol: No regular heavy drinking or recent history of abuse.
- Drugs: No recreational drug use.
- Medications:
- No prescription/OTC meds or supplements (including vitamins/herbal) for 14 days prior to dosing.
- No enzyme inhibitors/inducers (e.g., St. John's Wort) for 30 days prior.
- Pregnancy: Women cannot be pregnant or breastfeeding.
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Interventions
Period 1 (Day 1-2) is the control period. Intervention: In Period 2 (Day 3-7) participants will receive one esomeprazole 40mg capsule given orally on each of Days 3-6), followed by one ATH434 75mg tablet + one esomeprazole 40mg capsule (both given orally) on Day 7. Participants will receive ATH434 on day 1, esomeprazole on days 3-6 and ATH434 + esomeprazole on day 7. This is a fixed-sequence study and all participants will complete Period 1 before completing Period 2. To ensure the study drug is taken, all doses will be observed by clinic staff and followed by a hand and mouth check.
Locations(1)
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ACTRN12626000320358