A Phase 1, Randomised, Placebo-Controlled, Ascending Single and Multiple Dose Safety, Tolerability, Pharmacokinetic and Food Effect Study of PAT-1251 in Healthy Adult Subjects
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- PharmAkea, Inc.
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events
Study Overview
Brief Summary
A single-center, randomized, placebo-controlled study consisting of both a single ascending dose (SAD) and a multiple ascending dose (MAD) portion to evaluate the safety, tolerability, pharmacokinetics and effect of food using PAT-1251 orally administered to healthy subjects
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •body mass index (BMI) between 18.0 and 30.0 kg/m2, inclusive
- •body weight of 50 to 100 kg, inclusive
- •subjects must be in good health
Exclusion Criteria
- •male subjects who do not agree, or whose partners of childbearing potential do not agree, to use appropriate contraception
- •female subjects of childbearing potential who do not agree to use 2 acceptable methods of contraception
- •history of, any clinically significant major disorder
- •clinically significant allergic condition
- •significant history of alcoholism or drug/chemical abuse
- •use of any tobacco or nicotine-containing products
- •clinically significant abnormality in heart rate, blood pressure, temperature, respiration rate, electrocardiogram or clinical laboratory findings
- •positive urine drugs of abuse screen or alcohol breath test
Arms & Interventions
PAT-1251 Single Dose
Oral solution of PAT-1251, 150 - 4000 mg administered once
Intervention: PAT-1251 (Drug)
Placebo Single Dose
Matching placebo solution administered once
Intervention: Placebo (Drug)
PAT-1251 Multiple Dose
Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days
Intervention: PAT-1251 (Drug)
Placebo Multiple Dose
Matching placebo tablets administered daily for 7 days
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events
Time Frame: one to seven days
Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination
Secondary Outcomes
- Maximum Observed Plasma Concentration (Cmax)(one to seven days)
- Area Under the Plasma Concentration Versus Time Curve (AUC)(one to seven days)
- Time to Maximum Observed Plasma Concentration (Tmax)(one to seven days)
- Terminal elimination half-life (t½)(one to seven days)