Healthy VolunteersPhase 1NCT06547359
A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects
A Phase 1 study testing Obicetrapib 10mg and Ezetimibe 10mg in people with Healthy Volunteers, run by NewAmsterdam Pharma at 1 site in Canada.
Trial summary
A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Obicetrapib 10mg and Ezetimibe 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2024to 12 Nov 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
- Healthy, non-smoking, male and female subjects, from 18 to 65 years of age.
- BMI ≥18.5 and ≥30 kg/m2
- Females may be of childbearing or non-childbearing potential. Childbearing potential (physically capable of becoming pregnant). Non-childbearing potential: Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause and FSH and LH values consistent with being postmenopausal).
- Willing to use acceptable, effective methods of contraception.
- Able to tolerate venipuncture.
- Be informed of the nature of the study and give written consent prior to any study procedure.
Who cannot join
- History of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Known or suspected carcinoma.
- History of hypersensitivity or idiosyncratic reaction to obicetrapib, ezetimibe, or any other drug substances with similar activity.
- History of clinically significant angioedema.
- History of myopathy, rhabdomyolysis, or myalgia, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- History of pancreatitis, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
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- History of severe cutaneous adverse reactions (SCARs), Steven-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), or drug reaction with eosinophilic and systemic symptoms (DRESS), which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Presence of hepatic or renal dysfunction.
- History of malabsorption within the last year or presence of clinically significant gastrointestinal (GI) disease.
- Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
- History of drug or alcohol addiction requiring treatment.
- Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
- Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine.
- Difficulty fasting or consuming standard meals.
- Use of tobacco or nicotine-containing products within six (6) months prior to the first drug administration.
- Females who:
- Have used implanted, injected, intravaginal, or intrauterine hormonal contraceptives within six (6) months prior to the first drug administration;
- Have used oral or transdermal hormonal contraceptives within 21 days prior to the first drug administration;
- Are pregnant (serum β-hCG consistent with pregnancy); or
- Are breast-feeding.
- Donation or loss of whole blood (including clinical trials):
- ≥50 mL and <500 mL within 30 days prior to the first drug administration; or
- ≥500 mL within 56 days prior to the first drug administration.
- Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to the first drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
- On a special diet within 30 days prior to the first drug administration (e.g., liquid, protein, raw food diet).
- Have had a tattoo or body piercing within 30 days prior to the first drug administration.
- Have clinically significant findings in vital signs measurements.
- Have clinically significant findings in a 12-lead ECG.
- Have clinically significant abnormal laboratory values.
- Have significant diseases.
- Use of any of the following within 30 days prior to drug administration:
- Bile acid sequestrant (e.g., cholestyramine)
- Cyclosporine
- Digoxin
- Drugs that alter GI pH/movement (e.g., omeprazole, ranitidine)
- Enzyme-modifying drugs known to induce/inhibit hepatic drug metabolism
- Fibrates (e.g., fenofibrate)
- Gemfibrozil
- Glipizide
- Inducers and inhibitors of breast cancer resistant protein
- Inducers and inhibitors of CYP3A4
- Inducers and inhibitors of OATP1B1/OATP1B3
- Inducers and inhibitors of P-glycoprotein
- Statin
- Warfarin
- Have clinically significant findings from a physical examination.
Trial locations and contacts
1 site in 1 country.
About this study
A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects
Read the detailed description
A Study to Evaluate the PK of obicetrapib tablets with and without co-administration of daily doses of ezetimibe tablets and the PK of ezetimibe tablets with and without co-administration of daily doses of obicetrapib tablets.
- Conditions
- Healthy Volunteers
- Being tested
- Obicetrapib 10mg, Ezetimibe 10mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obicetrapib 10mgDrug
tablets
Ezetimibe 10mgDrug
tablets
| Study group | Role | What they receive |
|---|---|---|
| obicetrapib with and without co-administration of ezetimibe | Active comparator | Ezetimibe 10mg tablets daily from Days 1-17 plus obicetrapib 10mg tablets on Day -9 and Day 8 Receives: Drug: Obicetrapib 10mg; Drug: Ezetimibe 10mg |
| ezetimibe with and without co-administration of obicetrapib | Active comparator | Obicetrapib 10mg tablets daily from Days 1-15 plus ezetimibe10mg tablets on Day -3 and Day 12 Receives: Drug: Obicetrapib 10mg; Drug: Ezetimibe 10mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Maximum measured analyte concentration
Measured: time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
AUCt (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
The area under the analyte concentration versus time curve
Measured: time zero (0) to the time of the last measurable analyte concentration (t)
AUCinf (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
The area under the analyte concentration versus time curve
Measured: m time zero to infinity
Secondary outcomes (5)
Tmax (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Time of the maximum measured analyte concentration
Measured: zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
Kel (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
The apparent first-order elimination rate constant
Measured: time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
Thalf (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
The apparent elimination half-life
Measured: zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
CL/F (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Total body clearance
Measured: time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
Vd/F (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Apparent volume of distribution
Measured: time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start1 Oct 2024
- Primary completion12 Nov 2024
- Study completion12 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Open-label, two-cohort, fixed-sequence, drug-drug interaction study
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewAmsterdam Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Pharma Medica Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Mark M Feldman, Principal investigator, Pharma Medica Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06547359
- Sponsor's protocol ID
- TA-8995-14
- Status last verified
- Nov 2024
- First submitted
- 1 Aug 2024
- Last updated
- 14 Nov 2024
- 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 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06547359
- Acronym / sponsor ID
- TA-8995-14
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- NewAmsterdam PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Pharma Medica Research, Inc.
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 12 Nov 2024 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 9 Aug 2024 (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.
A Study to Evaluate Drug-Drug Interactions of Obicetrapib Tablets and Ezetimibe Tablets in Healthy Adult Subjects
Detailed description
A Study to Evaluate the PK of obicetrapib tablets with and without co-administration of daily doses of ezetimibe tablets and the PK of ezetimibe tablets with and without co-administration of daily doses of obicetrapib tablets.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open-label, two-cohort, fixed-sequence, drug-drug interaction study
| Arm | Type | Receives |
|---|---|---|
| obicetrapib with and without co-administration of ezetimibe | Active comparator | Drug: Obicetrapib 10mg, Drug: Ezetimibe 10mgEzetimibe 10mg tablets daily from Days 1-17 plus obicetrapib 10mg tablets on Day -9 and Day 8 |
| ezetimibe with and without co-administration of obicetrapib | Active comparator | Drug: Obicetrapib 10mg, Drug: Ezetimibe 10mgObicetrapib 10mg tablets daily from Days 1-15 plus ezetimibe10mg tablets on Day -3 and Day 12 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Healthy, non-smoking, male and female subjects, from 18 to 65 years of age.
- BMI ≥18.5 and ≥30 kg/m2
- Females may be of childbearing or non-childbearing potential. Childbearing potential (physically capable of becoming pregnant). Non-childbearing potential: Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause and FSH and LH values consistent with being postmenopausal).
- Willing to use acceptable, effective methods of contraception.
- Able to tolerate venipuncture.
Key exclusion criteria (46 listed)
- History of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Known or suspected carcinoma.
- History of hypersensitivity or idiosyncratic reaction to obicetrapib, ezetimibe, or any other drug substances with similar activity.
- History of clinically significant angioedema.
- History of myopathy, rhabdomyolysis, or myalgia, which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
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 |
|---|---|---|
| Obicetrapib 10mgtablets | Drug | ezetimibe with and without co-administration of obicetrapib, obicetrapib with and without co-administration of ezetimibe |
| Ezetimibe 10mgtablets | Drug | ezetimibe with and without co-administration of obicetrapib, obicetrapib with and without co-administration of ezetimibe |
Primary outcome
Cmax (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Time frame: time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
Maximum measured analyte concentration
AUCt (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Time frame: time zero (0) to the time of the last measurable analyte concentration (t)
The area under the analyte concentration versus time curve
AUCinf (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Time frame: m time zero to infinity
The area under the analyte concentration versus time curve
5 secondary outcomes
Tmax (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Time frame: zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
Kel (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Time frame: time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
Thalf (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Time frame: zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
CL/F (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Time frame: time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days
Vd/F (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide)
Time frame: time zero (0) to the time of the last measurable analyte concentration (t), up to 18 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 14 Nov 2024.
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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.
Mark M Feldman principal investigator
Pharma Medica Research, 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 Obicetrapib 10mg and Ezetimibe 10mg in people with Healthy Volunteers, run by NewAmsterdam Pharma 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 6 inclusion and 46 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 14 Nov 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 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.
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 (Obicetrapib, unconjugated ezetimibe, and ezetimibe glucuronide) (time frame: time zero (0) to the time of the last measurable analyte concentration (t), up to 18 days). 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 14 Nov 2024.