Healthy Volunteer StudyPhase 1NCT06050291
Investigating the Effect of Food on the Bioavailability of a Fixed Dose Combination of Obicetrapib and Ezetimibe
A Phase 1 study testing Fixed-Dose Combination (FDC) Tablet in people with Healthy Volunteer Study, run by NewAmsterdam Pharma at 1 site in United States.
Trial summary
This study will assess the effect of food on the bioavailability of obicetrapib and ezetimibe after a single-dose administration of a fixed-dose combination formulation of obicetrapib/ezetimibe, 10 mg/10 mg in healthy adult male and female subjects under fasted and fed conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer Study
- What is being tested?
- Fixed-Dose Combination (FDC) Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jan 2024to 7 Apr 2024
- 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
- Males and Females aged 18 to 65.
- Body Mass Index (BMI) of 18.5-29.9 kg/m², inclusive.
- Females of childbearing potential must be willing to use approved method of birth control.
- Blood pressure 90/60 - 140/90 mmHg, inclusive.
- Hemoglobin level above lower limit of normal.
- Good health.
Who cannot join
- Females who are pregnant, lactating or likely to become pregnant during the study.
- History of allergy, sensitivity to obicetrapib, ezetimibe or any components of the study products, or history of any drug hypersensitivity or intolerance that may compromise the safety of the subject.
- Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction especially hypothyroidism, renal or hepatic disorders, cardiovascular disorders, respiratory disorders, diabetes or obesity.
- Clinically significant history or presence of gastrointestinal disease or history of malabsorption within the last year.
- History of psychiatric disorders occurring within the last two years that required the subject to be hospitalized or treated with medication.
- Presence of a medical condition requiring regular treatment with prescription drugs.
Show all 20Show fewer
- Use of statins, cyclosporine, fibrates (e.g., fenofibrate), bile acid seuqstrants (e.g., cholestyramine), or coumarin anticoagulants within 30 days before initial dosing.
- Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes (especially inducers and inhibitors of CYP3A4) within 30 days before initial dosing.
- Use of any drug that can alter the absorption of other drugs by affecting gastrointestinal motility or by changing the gastric pH, in the opinion of the Investigator, within 14 days before initial dosing.
- Use of any drug that can increase or decrease the metabolism and excretion of the study drug, within 14 days before initial dosing.
- Receipt of any drug as part of a research study within 30 days before initial dosing.
- Previous participation in a research study with obicetrapib.
- Drug or alcohol addiction requiring treatment in the 12 months before initial dosing.
- History of excessive alcohol consumption (on average more than 14 units of alcohol/week) during the past 12 months.
- Donation or significant loss of whole blood (480 mL or more) within 30 days or plasma within 14 days before initial dosing.
- Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- Positive test results for drugs of abuse at screening.
- If female, has a positive pregnancy test at screening.
- Use of tobacco- or nicotine-containing products within 30 days before initial dosing.
- Difficulty swallowing tablets or capsules whole.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Assess the Effect of Food on the Bioavailability of Obicetrapib and Ezetimibe After Administration of a Fixed-Dose Combination Formulation of Obicetrapib/Ezetimibe, 10 mg/10 mg in Healthy Adult Subjects
This study will assess the effect of food on the bioavailability of obicetrapib and ezetimibe after a single-dose administration of a fixed-dose combination formulation of obicetrapib/ezetimibe, 10 mg/10 mg in healthy adult male and female subjects under fasted and fed conditions.
Read the detailed description
This is an open-label, single-dose, randomized, two-treatment, two-period, two-sequence crossover relative bioavailability study under fasted and fed conditions. It will assess the effect of food on the bioavailability of obicetrapib and ezetimibe after a single-dose administration of a fixed-dose combination formulation of obicetrapib/ezetimibe, 10 mg/10 mg in healthy adult male and female subjects under fasted and fed conditions. The screening period will be up to 28 days. Patients that are eligible will enter the clinical facility at least 10.5 hours prior to dosing. Depending on their randomization patients will be fed or fasted prior to dosing. They will remain confined for at least 24 hours. After leaving confinement, patients will return to the clinic 9 times for blood draws. At least 56 days after the first dosing, patients will return to the clinic and go through the same process. Those previously fed before dosing will be fasted and those previously fasted will be fed. Patients will return 9 times after their second confinement for additional blood draws.
- Conditions
- Healthy Volunteer Study
- Being tested
- Fixed-Dose Combination (FDC) Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fixed-Dose Combination (FDC) TabletDrug
Obicetrapib/Ezetimibe FDC tablet
| Study group | Role | What they receive |
|---|---|---|
| FDC Tablet Fed + Fast | Experimental | Participants will receive a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Tablet in a fed condition on Day 1 of treatment followed by a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Table in a fasted condition after, at a minimum, a 56 day washout. Receives: Drug: Fixed-Dose Combination (FDC) Tablet |
| FDC Tablet Fast + Fed | Experimental | Participants will receive a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Tablet in a fasted condition on Day 1 of treatment followed by a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Table in a fed condition after, at a minimum, a 56 day washout. Receives: Drug: Fixed-Dose Combination (FDC) Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum measured plasma concentration following each treatment.
Measured: 528.00 hours
AUC0-t
Area under the plasma concentration versus time curve from time zero to the time of the last measurable plasma concentration, as calculated by linear trapezoidal method.
Measured: 528.00 hours
AUC0-∞
Area under the plasma concentration versus time curve from time zero to infinity where AUC0-∞ = AUC0-t + Ct/λz. Ct is the last measurable concentration and λz is the terminal rate constant.
Measured: 528.00 hours
Secondary outcomes (8)
Tmax
Time of the maximum measured plasma concentration. If the maximum value occurs at more than one time point, Tmax is defined as the first time point with this value.
Measured: 528.00 hours
Tlag
Time delay in achieving Tmax
Measured: 528.00 hours
λz
First order rate constant associated with the terminal (log-linear) portion of the curve.
Measured: 528.00 hours
t½
The terminal half-life will be calculated as ln(2)/λz.
Measured: 528.00 hours
CL/F
Apparent oral systemic clearance, calculated as Dose/AUC0-∞
Measured: 528.00 hours
Vd/F
Apparent volume of distribution during terminal phase, calculated as Dose/(AUC0-∞ × λz)
Measured: 528.00 hours
R2 adjusted
Goodness of fit statistic for the terminal phase, adjusted for the number of points used in the estimation of λz.
Measured: 528.00 hours
AUC_%Extrap_obs
The residual area in percentage will be determined by the formula, [(AUC0-∞-AUC0-t)/AUC0-∞] × 100.
Measured: 528.00 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2023
- Study start20 Jan 2024
- Primary completion7 Apr 2024
- Study completion7 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteer StudyStudies 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
- Crossover
- Model description
- Open-Label, Single-Dose, Randomized, Two-Treatment, Two-Period, Two-Sequence, Crossover Study
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewAmsterdam Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06050291
- Sponsor's protocol ID
- OBEZ-103
- Status last verified
- Jan 2024
- First submitted
- 17 Sep 2023
- Last updated
- 5 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Effect of Food on the Bioavailability of Obicetrapib and Ezetimibe After Administration of a Fixed-Dose Combination Formulation of Obicetrapib/Ezetimibe, 10 mg/10 mg in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06050291
- Acronym / sponsor ID
- OBEZ-103
- Conditions
- Healthy Volunteer Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- NewAmsterdam PharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2024 (actual)
- Primary completion
- 7 Apr 2024 (actual)
- Study completion
- 7 Apr 2024 (actual)
- First posted
- 22 Sep 2023 (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.
This study will assess the effect of food on the bioavailability of obicetrapib and ezetimibe after a single-dose administration of a fixed-dose combination formulation of obicetrapib/ezetimibe, 10 mg/10 mg in healthy adult male and female subjects under fasted and fed conditions.
Detailed description
This is an open-label, single-dose, randomized, two-treatment, two-period, two-sequence crossover relative bioavailability study under fasted and fed conditions. It will assess the effect of food on the bioavailability of obicetrapib and ezetimibe after a single-dose administration of a fixed-dose combination formulation of obicetrapib/ezetimibe, 10 mg/10 mg in healthy adult male and female subjects under fasted and fed conditions. The screening period will be up to 28 days. Patients that are eligible will enter the clinical facility at least 10.5 hours prior to dosing. Depending on their randomization patients will be fed or fasted prior to dosing. They will remain confined for at least 24 hours. After leaving confinement, patients will return to the clinic 9 times for blood draws. At least 56 days after the first dosing, patients will return to the clinic and go through the same process. Those previously fed before dosing will be fasted and those previously fasted will be fed. Patients will return 9 times after their second confinement for additional blood draws.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-Label, Single-Dose, Randomized, Two-Treatment, Two-Period, Two-Sequence, Crossover Study
| Arm | Type | Receives |
|---|---|---|
| FDC Tablet Fed + Fast | Experimental | Drug: Fixed-Dose Combination (FDC) TabletParticipants will receive a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Tablet in a fed condition on Day 1 of treatment followed by a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Table in a fasted condition after, at a minimum, a 56 day washout. |
| FDC Tablet Fast + Fed | Experimental | Drug: Fixed-Dose Combination (FDC) TabletParticipants will receive a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Tablet in a fasted condition on Day 1 of treatment followed by a single Obicetrapib/Ezetimibe, 10 mg/10 mg FDC Table in a fed condition after, at a minimum, a 56 day washout. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and Females aged 18 to 65.
- Body Mass Index (BMI) of 18.5-29.9 kg/m², inclusive.
- Females of childbearing potential must be willing to use approved method of birth control.
- Blood pressure 90/60 - 140/90 mmHg, inclusive.
- Hemoglobin level above lower limit of normal.
Key exclusion criteria (20 listed)
- Females who are pregnant, lactating or likely to become pregnant during the study.
- History of allergy, sensitivity to obicetrapib, ezetimibe or any components of the study products, or history of any drug hypersensitivity or intolerance that may compromise the safety of the subject.
- Significant history or current evidence of chronic infectious disease, system disorders, organ dysfunction especially hypothyroidism, renal or hepatic disorders, cardiovascular disorders, respiratory disorders, diabetes or obesity.
- Clinically significant history or presence of gastrointestinal disease or history of malabsorption within the last year.
- History of psychiatric disorders occurring within the last two years that required the subject to be hospitalized or treated with medication.
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 |
|---|---|---|
| Fixed-Dose Combination (FDC) TabletObicetrapib/Ezetimibe FDC tablet | Drug | FDC Tablet Fast + Fed, FDC Tablet Fed + Fast |
Primary outcome
Cmax
Time frame: 528.00 hours
Maximum measured plasma concentration following each treatment.
AUC0-t
Time frame: 528.00 hours
Area under the plasma concentration versus time curve from time zero to the time of the last measurable plasma concentration, as calculated by linear trapezoidal method.
AUC0-∞
Time frame: 528.00 hours
Area under the plasma concentration versus time curve from time zero to infinity where AUC0-∞ = AUC0-t + Ct/λz. Ct is the last measurable concentration and λz is the terminal rate constant.
8 secondary outcomes
Tmax
Time frame: 528.00 hours
Tlag
Time frame: 528.00 hours
λz
Time frame: 528.00 hours
t½
Time frame: 528.00 hours
CL/F
Time frame: 528.00 hours
Vd/F
Time frame: 528.00 hours
R2 adjusted
Time frame: 528.00 hours
AUC_%Extrap_obs
Time frame: 528.00 hours
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 5 Jun 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Fixed-Dose Combination (FDC) Tablet in people with Healthy Volunteer Study, run by NewAmsterdam Pharma 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 6 inclusion and 20 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 5 Jun 2024. 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?
Cmax (time frame: 528.00 hours). The study lists 3 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 5 Jun 2024.