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Completed

NCT Number: NCT02852551

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Unit Ltd.

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PAT-1251

Drug

Placebo

Drug

Primary outcomes

  1. 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

  1. Maximum Observed Plasma Concentration (Cmax)

    Time frame: one to seven days

  2. Area Under the Plasma Concentration Versus Time Curve (AUC)

    Time frame: one to seven days

  3. Time to Maximum Observed Plasma Concentration (Tmax)

    Time frame: one to seven days

    Comparative pharmacokinetics of single dose administered in a fasted state and following a meal

  4. Terminal elimination half-life (t½)

    Time frame: one to seven days

Sponsors and collaborators

Lead sponsor

PharmAkea, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 2, 2016
Registry last updated
Nov 30, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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