NCT01282684

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jan 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2011

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 25, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2011

Completed
Last Updated

March 30, 2015

Status Verified

March 1, 2015

Enrollment Period

3 months

First QC Date

January 18, 2011

Last Update Submit

March 26, 2015

Conditions

Healthy

Keywords

SafetyTolerabilityPharmacokineticsPLX5622

Outcome Measures

Primary Outcomes (2)

  • 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 (3)

  • Pharmacokinetic profile: Measurement of area under the plasma-concentration-time curve

    7 days

  • Pharmacokinetic evaulation: Measurement of Peak Concentration

    7 days

  • Pharmacokinetic profile: Measurement of half life and terminal elimination rate constant

    7 Days

Study Arms (7)

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

single oral dose of 1400 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

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

PLX5622DRUG

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 PLX5622single oral dose of 1400 mg PLX5622single oral dose of 1600 mg PLX5622single oral dose of 200 mg PLX5622single oral dose of 400 mg PLX5622single oral dose of 800 mg PLX5622
PlaceboDRUG

Matching placebo for PLX5622.

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cetero Research

Fargo, North Dakota, 58104, United States

Location

MeSH Terms

Interventions

PLX5622

Study Officials

  • Gregory Haugen, MD

    Cetero Research, San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2011

First Posted

January 25, 2011

Study Start

January 1, 2011

Primary Completion

April 1, 2011

Study Completion

April 1, 2011

Last Updated

March 30, 2015

Record last verified: 2015-03

Locations

US(1)