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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02852551

Enrollment

Registered

2016-08-02

Start date

2016-07-31

Completion date

2016-11-30

Last updated

2016-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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

Interventions

DRUGPAT-1251

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026