HealthyPhase 1NCT01282684
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PLX5622 in Healthy Adult Volunteers
A Phase 1 study testing PLX5622 in people with Healthy, run by Plexxikon at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- PLX5622
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Apr 2011
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- PLX5622, Placebo
- Keywords
- Safety, Tolerability, Pharmacokinetics, PLX5622
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDrug
Matching placebo for PLX5622.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 7 days
Secondary outcomes (3)
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].
Measured: 7 days
Pharmacokinetic evaulation: Measurement of Peak Concentration
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 peak concentration (Cmax) and time to peak concentration (Tmax).
Measured: 7 days
Pharmacokinetic profile: Measurement of half life and terminal elimination rate constant
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 half-life (T1/2), and terminal elimination rate constant (Kel).
Measured: 7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2011 (estimated)
- Study startJan 2011
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Plexxikon
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gregory Haugen, MD, Principal investigator, Cetero Research, San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01282684
- Sponsor's protocol ID
- PLX115-01
- Status last verified
- Mar 2015
- First submitted
- 18 Jan 2011
- Last updated
- 30 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01282684
- Acronym / sponsor ID
- PLX115-01
- Conditions
- Healthy
- Keywords
- Safety, Tolerability, Pharmacokinetics, PLX5622
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- PlexxikonIndustry (pharma, biotech, devices)
- Study start
- Jan 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 25 Jan 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| single oral dose of 200 mg PLX5622 | Active comparator | Drug: PLX56226 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo. |
| single oral dose of 400 mg PLX5622 | Active comparator | Drug: PLX56226 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo. |
| single oral dose of 800 mg PLX5622 | Active comparator | Drug: PLX56226 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo. |
| single oral dose of 1600 mg PLX5622 | Active comparator | Drug: PLX56226 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo. |
| single oral dose of 1000 mg PLX5622 | Active comparator | Drug: PLX56226 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo. |
| single oral dose of 1400 mg PLX5622 | Active comparator | Drug: PLX56226 subjects will be randomized to take a single oral dose of PLX5622 and 2 subjects will be randomized to take placebo. |
| Placebo | Placebo comparator | Drug: Placebo2 patients per cohort will be randomly assigned to take placebo. 12 patients total will be randomized to take placebo in this study. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLX5622PLX5622 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 | Drug | single oral dose of 1000 mg PLX5622, single oral dose of 1400 mg PLX5622, single oral dose of 1600 mg PLX5622, single oral dose of 200 mg PLX5622, single oral dose of 400 mg PLX5622, single oral dose of 800 mg PLX5622 |
| PlaceboMatching placebo for PLX5622. | Drug | Placebo |
Primary outcome
Safety-Number of patients with adverse events
Time frame: 7 days
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.
Tolerability-Number of patients with adverse events
Time frame: 7 days
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.
3 secondary outcomes
Pharmacokinetic profile: Measurement of area under the plasma-concentration-time curve
Time frame: 7 days
Pharmacokinetic evaulation: Measurement of Peak Concentration
Time frame: 7 days
Pharmacokinetic profile: Measurement of half life and terminal elimination rate constant
Time frame: 7 Days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Haugen, MD principal investigator
Cetero Research, San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PLX5622 in people with Healthy, run by Plexxikon at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety-Number of patients with adverse events (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2015.