Study to Evaluate the Safety, Tolerability, and Pharmacok... | NCT01282684

NCT01282684

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
single oral dose of 200 mg PLX5622	Active Comparator	6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.	Drug: PLX5622
single oral dose of 400 mg PLX5622	Active Comparator	6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.	Drug: PLX5622
single oral dose of 800 mg PLX5622	Active Comparator	6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.	Drug: PLX5622
single oral dose of 1600 mg PLX5622	Active Comparator	6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.	Drug: PLX5622
single oral dose of 1000 mg PLX5622	Active Comparator	6 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo.	Drug: PLX5622

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PLX5622	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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety-Number of patients with adverse events	Subjects will take one oral dose of PLX5622 on Day 1. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), adverse events, hematology, serum chemistry, coagulation, and urinalysis will be used to assess safety throughout the Days 1-4 of the study and on the follow up study visit on day 7. Adverse events will be monitored and reviewed for safety issues/abnormal changes in the above mentioned tests.	7 days
Tolerability-Number of patients with adverse events	Subjects will take one oral dose of PLX5622 on Day 1. Physical examinations, vital signs, 12-lead electrocardiograms (ECG), adverse events, hematology, serum chemistry, coagulation, and urinalysis will be used to assess safety throughout the Days 1-4 of the study and on the follow up study visit on day 7. Adverse events will be monitored and reviewed for tolerability issues/abnormal changes in the above mentioned tests.	7 days

Secondary Outcomes

Measure	Description	Time Frame
Pharmacokinetic profile: Measurement of area under the plasma-concentration-time curve	Pharmacokinetic (PK) samples will be collected prior to dosing and at 0.5, 1, 2, 4, 8, 12, 24, 26, 48, 60 and 72 hours following dosing. The pharmacokinetic profile of plasma PLX5622 will be analyzed by measurement of area under the plasma concentration-time curve [AUC0-t, AUC0-inf, AUC0-24].	7 days

Eligibility Module

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