None listed
Conditions
Brief 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.
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
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.
Sponsors
Alterity Therapeutics Limited
Study design
Allocation
Non-randomised trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
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 criteria
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.
Outcome results
None listed