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

Healthy Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02852551
• Other study ID #: PAT-1251-CL-001
• Status: Completed
• Phase: Phase 1
• First received: July 15, 2016
• Last updated: November 28, 2016
• Start date: July 2016
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: PharmAkea, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• PAT-1251

• Placebo

Locations

Country	Name	City	State
United Kingdom	Covance Clinical Research Unit Ltd.	Leeds

Sponsors (1)

Lead Sponsor	Collaborator
PharmAkea, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Maximum Observed Plasma Concentration (Cmax)		one to seven days
Secondary	Area Under the Plasma Concentration Versus Time Curve (AUC)		one to seven days
Secondary	Time to Maximum Observed Plasma Concentration (Tmax)	Comparative pharmacokinetics of single dose administered in a fasted state and following a meal	one to seven days
Secondary	Terminal elimination half-life (t½)		one to seven days

External Links

•   Sponsor Website