Food EffectPhase 1NCT05187169
Food Effect of VS-6766 in Healthy Adult Subjects
A Phase 1 study testing VS-6766 in people with Food Effect, run by Verastem, Inc. at 1 site in United States.
Trial summary
An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766 Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Food Effect
- What is being tested?
- VS-6766
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2021to 12 Apr 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age, inclusive, at the screening visit.
- Must follow protocol specified contraception guidance.
- Continuous non-smoker who has not used tobacco/nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
- Medically healthy with no clinically significant medical history.
- Able to swallow capsules.
- Understands the study procedures in the informed consent form (ICF), and be willing and able to comply with the protocol.
Who cannot join
- Presence of systemic or severe infection.
- History or presence of a significant medical condition or disease which is not completely resolved.
- History or presence of alcohol or drug abuse
- History or presence of hypersensitivity or reaction to the study drug or related compounds.
- History of tuberculosis.
- Presence of any fever within 2 weeks prior to first dosing.
Show all 14Show fewer
- Females able to have children.
- Females who are pregnant or lactating.
- Presence of HIV.
- Must be able to refrain from using any drugs, including prescription and non-prescription medications beginning 28 days prior to the first dosing.
- Lactose Intolerance.
- Donation of blood or significant blood loss or blood transfusion within 56 days prior to the first dosing.
- Plasma donation within 7 days prior to the first dosing.
- Participation in another clinical study within 30 days prior to the first dosing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766
An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766
Read the detailed description
This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.
On Day 1 of each period, subjects will receive a single oral dose of VS-6766 administered in a 2-way crossover fashion either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for VS-6766 will be collected predose and postdose. There will be a washout period between doses.
- Conditions
- Food Effect
- Being tested
- VS-6766
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VS-6766Drug
Dual RAF/MEK inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Active comparator | 4.0 mg VS-6766, following an overnight fast of at least 10 hours Receives: Drug: VS-6766 |
| Treatment B | Active comparator | 4.0 mg VS-6766, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast Receives: Drug: VS-6766 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-t
Area under plasma Concentration (AUC) 0 to t
Measured: 30 days
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-120
Area under plasma Concentration (AUC) from 0-120 minutes
Measured: 30 days
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-inf
Area under plasma Concentration (AUC) from zero to infinity
Measured: 30 days
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC%extrap
Area under plasma Concentration (AUC) extrapolated
Measured: 30 days
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Cmax
Cmax for VS-6766 administered with and without food.
Measured: 30 days
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Tlag
absorption lag-time (Tlag)
Measured: 30 days
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Tmax
time of Maximum concentration (Tmax)
Measured: 30 days
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Kel
Elimination rate (Kel)
Measured: 30 days
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: T1/2
concentration Half-life (T1/2)
Measured: 30 days
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: CL/F
Oral Clearance (CL/F)
Measured: 30 days
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Vz/F
Apparent Volume of Distribution (Vz/F) for VS-6766 administered with and without food.
Measured: 30 days
Secondary outcomes (1)
To assess the safety and tolerability of a single-dose of VS-6766 administered with or without a standardized high-fat/high-calorie meal in healthy adult subjects.
Treatment emergent adverse events/ treatment emergent serious adverse events - their frequency, duration and severity, lab parameters, vital signs, ECG and ophthalmologic changes
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start16 Dec 2021
- Primary completion12 Apr 2022
- Study completion12 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Food EffectStudies of the same condition, open and under way.
- More trials run by Verastem, Inc.The sponsor's other registered studies.
- 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
- Crossover
- Model description
- This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Verastem, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Louis Denis, MD, Study director, Verastem, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187169
- Sponsor's protocol ID
- VS-6766-101
- Status last verified
- May 2022
- First submitted
- 23 Dec 2021
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766
- ClinicalTrials.gov ID
- NCT05187169
- Acronym / sponsor ID
- VS-6766-101
- Conditions
- Food Effect
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Verastem, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 12 Apr 2022 (actual)
- Study completion
- 12 Apr 2022 (actual)
- First posted
- 11 Jan 2022 (actual)
- 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.
An Open-Label, 2-Way, 2-Period Crossover Study of Orally Administered VS-6766 in Healthy Adult Subjects to Determine the Effect of Food on the Pharmacokinetics of VS-6766
Detailed description
This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.
On Day 1 of each period, subjects will receive a single oral dose of VS-6766 administered in a 2-way crossover fashion either under fasting conditions or following a standardized high-fat/high-calorie meal. PK sampling for VS-6766 will be collected predose and postdose. There will be a washout period between doses.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an open-label, randomized, 2-way, 2-period crossover, Food Effect study.
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Active comparator | Drug: VS-67664.0 mg VS-6766, following an overnight fast of at least 10 hours |
| Treatment B | Active comparator | Drug: VS-67664.0 mg VS-6766, administered 30 minutes after the start of a high-fat/high-calorie meal breakfast |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy, adult, male or female (of non-childbearing potential only), 18-55 years of age, inclusive, at the screening visit.
- Must follow protocol specified contraception guidance.
- Continuous non-smoker who has not used tobacco/nicotine-containing products for at least 3 months prior to the first dosing based on subject self-reporting.
- Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m2 at the screening visit.
- Medically healthy with no clinically significant medical history.
Key exclusion criteria (14 listed)
- Presence of systemic or severe infection.
- History or presence of a significant medical condition or disease which is not completely resolved.
- History or presence of alcohol or drug abuse
- History or presence of hypersensitivity or reaction to the study drug or related compounds.
- History of tuberculosis.
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 |
|---|---|---|
| VS-6766Dual RAF/MEK inhibitor | Drug | Treatment A, Treatment B |
Primary outcome
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-t
Time frame: 30 days
Area under plasma Concentration (AUC) 0 to t
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-120
Time frame: 30 days
Area under plasma Concentration (AUC) from 0-120 minutes
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-inf
Time frame: 30 days
Area under plasma Concentration (AUC) from zero to infinity
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC%extrap
Time frame: 30 days
Area under plasma Concentration (AUC) extrapolated
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Cmax
Time frame: 30 days
Cmax for VS-6766 administered with and without food.
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Tlag
Time frame: 30 days
absorption lag-time (Tlag)
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Tmax
Time frame: 30 days
time of Maximum concentration (Tmax)
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Kel
Time frame: 30 days
Elimination rate (Kel)
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: T1/2
Time frame: 30 days
concentration Half-life (T1/2)
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: CL/F
Time frame: 30 days
Oral Clearance (CL/F)
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: Vz/F
Time frame: 30 days
Apparent Volume of Distribution (Vz/F) for VS-6766 administered with and without food.
1 secondary outcome
To assess the safety and tolerability of a single-dose of VS-6766 administered with or without a standardized high-fat/high-calorie meal in healthy adult subjects.
Time frame: 30 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 10 May 2022.
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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.
Louis Denis, MD study director
Verastem, Inc.
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 VS-6766 in people with Food Effect, run by Verastem, Inc. 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 7 inclusion and 14 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 10 May 2022. 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. 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?
Plasma Pharmacokinetics (PK) of a single dose of VS-6766 after a standardized high-fat/high-calorie meal and after fasting: AUC0-t (time frame: 30 days). The study lists 11 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 10 May 2022.