Clinical trial NCT01282684: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PLX5622 in Healthy Adult Volunteers
Official title: A Phase 1 First in Human Double-Blind, Placebo-Controlled, Randomized, Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PLX5622 in Healthy Adult Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Tolerability
Pharmacokinetics
PLX5622
Lead sponsor: Plexxikon
Sponsor class: INDUSTRY
First posted: 2011-01-25
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Safety-Number of patients with adverse events
timeFrame: 7 days
measure: Tolerability-Number of patients with adverse events
timeFrame: 7 days
Secondary outcomes:
measure: Pharmacokinetic profile: Measurement of area under the plasma-concentration-time curve
timeFrame: 7 days
measure: Pharmacokinetic evaulation: Measurement of Peak Concentration
timeFrame: 7 days
measure: Pharmacokinetic profile: Measurement of half life and terminal elimination rate constant
timeFrame: 7 Days
Other outcomes:
Locations:
city: Fargo
country: United States
facility: Cetero Research
state: North Dakota
Study officials:
affiliation: Cetero Research, San Antonio
name: Gregory Haugen, MD
role: PRINCIPAL_INVESTIGATOR
References: