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

NCT ID: NCT01282684

Last Updated: 2015-03-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-04-30

Brief Summary

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

single oral dose of 200 mg PLX5622

6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.

Group Type: ACTIVE_COMPARATOR

PLX5622

Intervention Type: DRUG

PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor. The drug product is available in capsule form, to be taken orally, in dosage strengths of 25 mg and 100 mg with matching placebo

single oral dose of 400 mg PLX5622

6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.

Group Type: ACTIVE_COMPARATOR

PLX5622

Intervention Type: DRUG

PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor. The drug product is available in capsule form, to be taken orally, in dosage strengths of 25 mg and 100 mg with matching placebo

single oral dose of 800 mg PLX5622

6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.

Group Type: ACTIVE_COMPARATOR

PLX5622

Intervention Type: DRUG

PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor. The drug product is available in capsule form, to be taken orally, in dosage strengths of 25 mg and 100 mg with matching placebo

single oral dose of 1600 mg PLX5622

6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.

Group Type: ACTIVE_COMPARATOR

PLX5622

Intervention Type: DRUG

PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor. The drug product is available in capsule form, to be taken orally, in dosage strengths of 25 mg and 100 mg with matching placebo

single oral dose of 1000 mg PLX5622

6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.

Group Type: ACTIVE_COMPARATOR

PLX5622

Intervention Type: DRUG

PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor. The drug product is available in capsule form, to be taken orally, in dosage strengths of 25 mg and 100 mg with matching placebo

single oral dose of 1400 mg PLX5622

6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.

Group Type: ACTIVE_COMPARATOR

PLX5622

Intervention Type: DRUG

PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor. The drug product is available in capsule form, to be taken orally, in dosage strengths of 25 mg and 100 mg with matching placebo

Placebo

2 patients per cohort will be randomly assigned to take placebo. 12 patients total will be randomized to take placebo in this study.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo for PLX5622.

Interventions

PLX5622

PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor. The drug product is available in capsule form, to be taken orally, in dosage strengths of 25 mg and 100 mg with matching placebo

Intervention Type: DRUG

Placebo

Matching placebo for PLX5622.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Plexxikon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Haugen, MD

Role: PRINCIPAL_INVESTIGATOR

Cetero Research, San Antonio

Locations

Cetero Research

Fargo, North Dakota, United States

Countries

United States

Other Identifiers

PLX115-01

Identifier Type: -

Identifier Source: org_study_id