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

P

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

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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