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

PharmAkea

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Placebo; Drug: PAT-1251

Study type: Interventional

Funder types: Industry

Identifiers

NCT02852551

PAT-1251-CL-001

Details and patient eligibility

About

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

Enrollment: 78 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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78 participants in 4 patient groups, including a placebo group

PAT-1251 Single Dose

Experimental group

Description:

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

Treatment:

Drug: PAT-1251

Placebo Single Dose

Placebo Comparator group

Description:

Matching placebo solution administered once

Treatment:

Drug: Placebo

PAT-1251 Multiple Dose

Experimental group

Description:

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

Treatment:

Drug: PAT-1251

Placebo Multiple Dose

Experimental group

Description:

Matching placebo tablets administered daily for 7 days

Treatment:

Drug: Placebo