Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PLX5622 in Healthy Adult Volunteers

Plexxikon

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: PLX5622

Study type

Interventional

Funder types

Industry

Identifiers

NCT01282684

PLX115-01

Details and patient eligibility

About

The purpose of this study is to study the safety and tolerability of a single dose of PLX5622 in healthy, adult human volunteers. This will be the first time PLX5622 has been taken by humans.

Enrollment

32 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy adult male and female subjects, 18-65 years of age inclusive
BMI 18 to 32 kg/m2 inclusive
Female subjects must be surgically sterile or postmenopausal for the past year and have a negative urine pregnancy test. Male subjects and their partners of childbearing potential must be willing to use two methods of contraception, one of which must be a barrier method (e.g. condom) for up to 90 days after the last study drug administration.
Willing and able to remain in the clinical research unit as required by the protocol
Willing and able to provide written informed consent prior to any study related procedures and to comply with all study requirements

Exclusion criteria

History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease
History or presence of any disease, medical condition, or surgery, which may have an effect on drug absorption, metabolism, distribution, or excretion of the investigational product
Laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis) that the investigator believes show clinically relevant significant abnormalities for the normal reference range
Any abnormality in the ECG (including QTc ≥450 msec) that in the opinion of the investigator increases the risk of participating in the study
History or presence of alcoholism or drug abuse within the year prior to dosing
Tobacco use, either current or within 3 months prior to dosing
Use of any prescription medications or herbal remedies within 14 days prior to dosing, or use of over-the-counter medications or vitamins within 7 days prior to dosing, unless approved by the Sponsor
Donation of whole blood within 56 days prior to the study
Plasma donation within 7 days prior to the study
Participation in an investigational device study or receipt of an investigational drug within 4 weeks prior to dosing
Positive urine test for drugs of abuse
Confirmed HIV, hepatitis B, or hepatitis C infection

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

32 participants in 7 patient groups, including a placebo group

single oral dose of 200 mg PLX5622

Active Comparator group

Description: