Single and Multiple Dose Safety, Tolerability, PK and Food Effect Study of PAT-1251 in Healthy Adult Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: PAT-1251; Drug: Placebo

• Registration Number: NCT02852551
• Lead Sponsor: PharmAkea, Inc.

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2016-07-15
• Study First Submitted QC: 2016-07-28
• Study First Posted: 2016-08-02
• Status Verified: 2016-11
• Primary Completion: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAT-1251 Single Dose	PAT-1251	Oral solution of PAT-1251, 150 - 4000 mg administered once
Placebo Single Dose	Placebo	Matching placebo solution administered once
PAT-1251 Multiple Dose	PAT-1251	Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days
Placebo Multiple Dose	Placebo	Matching placebo tablets administered daily for 7 days

Primary Outcome Measures

Name	Time	Method
Incidence of Treatment-Emergent Adverse Events	one to seven days	Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination

Secondary Outcome Measures

Name	Time	Method
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	Comparative pharmacokinetics of single dose administered in a fasted state and following a meal
Terminal elimination half-life (t½)	one to seven days

Trial Locations

Locations (1)

Covance Clinical Research Unit Ltd.; 🇬🇧 Leeds, United Kingdom