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

NCT02852551 | Completed Phase 1

• 1 other identifier: PAT-1251-CL-001
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  Determination of adverse events will include assessment of vital signs, ECG, clinical laboratory and physical examination

  one to seven days

Secondary Outcomes (4)

• 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

Study Arms (4)

PAT-1251 Single Dose

EXPERIMENTAL

Oral solution of PAT-1251, 150 - 4000 mg administered once

Drug: PAT-1251

Placebo Single Dose

PLACEBO COMPARATOR

Matching placebo solution administered once

Drug: Placebo

PAT-1251 Multiple Dose

EXPERIMENTAL

Oral tablet(s) of PAT-1251 up to 2000 mg administered daily for 7 days

Drug: PAT-1251

Placebo Multiple Dose

EXPERIMENTAL

Matching placebo tablets administered daily for 7 days

Drug: Placebo

Interventions

PAT-1251 DRUG

PAT-1251 Multiple Dose; PAT-1251 Single Dose

Placebo DRUG

Placebo Multiple Dose; Placebo Single Dose

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• PharmAkea, Inc.: lead

Study Sites (1)

Covance Clinical Research Unit Ltd.

Leeds, LS2 9LH, United Kingdom

Location

Related Links

• Sponsor Website

Study Officials

• Kevin Holme, Ph.D.

  PharmAkea, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2016
• First Posted: August 2, 2016
• Study Start: July 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: November 30, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)