HealthyNCT02117245
Single Dose Comparative Bioavailability Study Of MGCD265 In Healthy Male And Female Volunteers
An observational study of Healthy, run by Mirati Therapeutics Inc. at 1 site in Canada.
Trial summary
The objective of this study is to assess the bioavailability of the MGCD265 formulation following oral administration under fed conditions (Treatment-1) as compared to fasting conditions (Treatment-2) in healthy male and female volunteers. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2011to Nov 2012
- Phase
- Observational
- 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 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy male and female volunteers.
Who may be able to join
- Male or female volunteer
- Volunteer age of 40 to 65 years
- Females of childbearing potential using a stable contraceptive method at least 14 days prior to screening and willing to use acceptable birth control methods from 7 days prior to first dose until 30 days after last dose of study drug:
- Female volunteers will be considered of non childbearing potential and eligible if:
- Amenorrhea for at least 1 year;
- Hysterectomy;
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- Bilateral oophorectomy at least 6 weeks prior to first dose;
- Bilateral tubal ligation at least 6 months prior to first dose;
- Hysteroscopic sterilization.
- Male volunteers who agree to be abstinent or use acceptable contraception methods in collaboration with their female partner from the time of taking the first dose until 90 days after the last dose of study drug:
- Male volunteers who also agree to not donate sperm from the time of taking the first dose until 90 days after the last dose.
- Volunteer with a body mass index (BMI) greater than or equal to 18.50 and below 30.00 kg/m2
- Non- or ex smokers for at least 6 months.
- Availability for the entire study period
- Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements
- Clinical laboratory values within the laboratory's stated normal range; or they must be without any clinical significance
- Have no clinically significant diseases captured in medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations
- Willingness to adhere to protocol requirements
- The informed consent form must be signed by all volunteers, prior to participation in the study.
Who cannot join
- Females who are pregnant or are lactating
- History of significant hypersensitivity reactions to any substance or drug
- History or presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs
- Seated blood pressure higher than and equal to 140/90 mmHg at screening
- Seated blood pressure higher than and equal to 140/90 mmHg before drug administration
- History or predisposition to cardiovascular illness
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- History or predisposition to thrombotic or hemorrhagic events, bleeding diathesis or coagulopathy, gastrointestinal or other conditions with risk of perforation, presence of a non-healing wound, ulcer or fracture
- Presence of significant pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease
- No major surgery within 28 days prior to first dose
- Suicidal tendency, disposition to seizures, state of confusion, clinically relevant psychiatric diseases
- Presence of out-of-range cardiac interval or ECG abnormalities
- Maintenance therapy with any drug, or history of drug dependency or alcohol abuse
- Any clinically significant illness in the previous 28 days before day 1 of study
- Use of any enzyme-modifying drugs in the previous 28 days before day 1 of study
- Use of any drugs known to induce or inhibit hepatic metabolism in the previous 28 days before day 1 of study
- Any history of tuberculosis and/or prophylaxis for tuberculosis
- Positive urine screening of ethanol and/or drugs of abuse
- Positive results to HIV, HBsAg or anti-Hepatitis C Virus tests
- Females who are pregnant
- Volunteers who took an Investigational Product or donated 50 mL or more of blood in the previous 28 days before day 1 of this study
- Donation of 500 mL or more of blood in the previous 56 days before day 1 of this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I Single Dose Comparative Bioavailability Study Of MGCD265 In Healthy Male And Female Volunteers
The objective of this study is to assess the bioavailability of the MGCD265 formulation following oral administration under fed conditions (Treatment-1) as compared to fasting conditions (Treatment-2) in healthy male and female volunteers.
Read the detailed description
The study objective is to assess the bioavailability of the MGCD265 formulation following oral administration under fed conditions (Treatment-1) as compared to fasting conditions (Treatment-2) in healthy male and female volunteers.
- Conditions
- Healthy
- Keywords
- Food effect on MGCD265 bioavailability in healthy volunteers
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma concentration (Cmax) of MGCD265.
Bioavailability of study drug under fed conditions compared to fasting conditions in healthy male and female volunteers.
Measured: 26 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startDec 2011
- Primary completionOct 2012
- Study completionNov 2012
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirati Therapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Manuela Juretic, Study director, MethylGene Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117245
- Sponsor's protocol ID
- 265-105
- Status last verified
- Jan 2015
- First submitted
- 7 May 2012
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Single Dose Comparative Bioavailability Study Of MGCD265 In Healthy Male And Female Volunteers
- ClinicalTrials.gov ID
- NCT02117245
- Acronym / sponsor ID
- 265-105
- Conditions
- Healthy
- Keywords
- Food effect on MGCD265 bioavailability in healthy volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Mirati Therapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 17 Apr 2014 (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 objective of this study is to assess the bioavailability of the MGCD265 formulation following oral administration under fed conditions (Treatment-1) as compared to fasting conditions (Treatment-2) in healthy male and female volunteers.
Detailed description
The study objective is to assess the bioavailability of the MGCD265 formulation following oral administration under fed conditions (Treatment-1) as compared to fasting conditions (Treatment-2) in healthy male and female volunteers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy male and female volunteers.
Key inclusion criteria (19 listed)
- Male or female volunteer
- Volunteer age of 40 to 65 years
- Females of childbearing potential using a stable contraceptive method at least 14 days prior to screening and willing to use acceptable birth control methods from 7 days prior to first dose until 30 days after last dose of study drug:
- Female volunteers will be considered of non childbearing potential and eligible if:
- Male volunteers who agree to be abstinent or use acceptable contraception methods in collaboration with their female partner from the time of taking the first dose until 90 days after the last dose of study drug:
Key exclusion criteria (21 listed)
- Females who are pregnant or are lactating
- History of significant hypersensitivity reactions to any substance or drug
- History or presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with absorption, distribution, metabolism or excretion of drugs
- Seated blood pressure higher than and equal to 140/90 mmHg at screening
- Seated blood pressure higher than and equal to 140/90 mmHg before drug administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peak Plasma concentration (Cmax) of MGCD265.
Time frame: 26 days
Bioavailability of study drug under fed conditions compared to fasting conditions in healthy male and female volunteers.
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 8 Jan 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.
Manuela Juretic study director
MethylGene Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Mirati Therapeutics Inc. at 1 site in Canada.
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 19 inclusion and 21 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 8 Jan 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Peak Plasma concentration (Cmax) of MGCD265. (time frame: 26 days). 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 8 Jan 2015; AzTrials last refreshed its copy on 6 Nov 2026.