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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy

In brief

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.

Key facts

Study ID

NCT01282684

Run by

Plexxikon

People needed

32

Starts

2011-01-01

Expected to finish

2011-04-01

Last updated by the study team

2015-03-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cetero Research — Fargo, North Dakota, United States

Full record on ClinicalTrials.gov

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