Healthy VolunteersPhase 1NCT06081166
A Drug-drug Interaction Study Evaluating the PK Effects of Obicetrapib on Atorvastatin and Rosuvastatin
A Phase 1 study testing Obicetrapib, Atorvastatin Calcium and Rosuvastatin Calcium in people with Healthy Volunteers, run by NewAmsterdam Pharma at 1 site in Canada.
Trial summary
A study to evaluate impact of Obicetrapib on PK levels of Atorvastatin and Rosuvastatin 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, Atorvastatin Calcium and Rosuvastatin Calcium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteCanada
- Study dates
- 11 Nov 2023to 22 Jan 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
- Cohort 1 Healthy, non-smoking, male and female subjects, from 18 to 65 years of age Cohort 2 Healthy, non-smoking, male and female subjects of non-Asian origin, 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:
- o Physically capable of becoming pregnant
- Non-childbearing potential:
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- 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
- Known history or presence 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.
- Known history or presence of hypersensitivity or idiosyncratic reaction to atorvastatin, rosuvastatin, obicetrapib, or any other drug substances with similar activity.
- Known history or presence of chronic infectious disease, system disorders, organ dysfunction especially hypothyroidism, stroke or transient ischemic attack, myopathy, rhabdomyolysis, renal or hepatic disorders, diabetes, or obesity which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Known history or presence of clinically significant lactose, galactose, or fructose intolerance.
- Subjects of Asian origin (Cohort 2 only).
Show all 55Show fewer
- 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 consuming standard meals.
- Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
- Females who:
- Have used implanted, injected, intravaginal, or intrauterine hormonal contraceptives within 6 months prior to drug administration;
- Have used oral or transdermal hormonal contraceptives within 21 days prior to drug administration;
- Are pregnant (serum 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 drug administration;
- ≥500 mL within 56 days prior to drug administration.
- Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to 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 drug administration (e.g., liquid, protein, raw food diet).
- Have had a tattoo or body piercing within 30 days prior to 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.
- Have clinically significant findings from a physical examination.
- Use of any of the following within 30 days prior to drug administration:
- Anticoagulants
- Anti-fungals (e.g., voriconazole, itraconazole)
- Anti-virals
- Capmatinib
- Cholestyramine
- Colchicine
- Cyclosporine
- Darolutamide
- Digoxin
- Drugs known to induce/inhibit hepatic drug metabolism or alter GI pH/movement (e.g., omeprazole, ranitidine)
- Fostamatinib
- Inducers and inhibitors of CYP3A4
- Inducers and inhibitors of breast cancer resistant protein
- Inducers and inhibitors of OATP1B1/OATP1B3
- Inducers and inhibitors of P-glycoprotein)
- Macrolide antibiotic medications (e.g., erythromycin)
- Niacin
- Regorafenib
- Statins
- Tafamidis
- Teriflunomide
- Drugs that decrease levels of endogenous steroid hormones (e.g., ketoconazole, spironolactone, cimetidine)
- Febuxostat
- Fibrates (e.g., fenofibrate, gemfibrozil)
- Warfarin
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Atorvastatin Calcium Tablets or Rosuvastatin Calcium Tablets in Healthy Adult Subjects
A study to evaluate impact of Obicetrapib on PK levels of Atorvastatin and Rosuvastatin
Read the detailed description
A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Atorvastatin Calcium Tablets or Rosuvastatin Calcium Tablets in Healthy Adult Subjects
- Conditions
- Healthy Volunteers
- Being tested
- Obicetrapib, Atorvastatin Calcium, Rosuvastatin Calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObicetrapibDrug
Also called tablets
obicetrapib 10 mg daily
Atorvastatin CalciumDrug
Also called tablets
Atorvastatin 80 mg
Rosuvastatin CalciumDrug
Also called tablets
Rosuvastatin 40 mg
| Study group | Role | What they receive |
|---|---|---|
| obicetrapib + atorvastatin | Active comparator | Obicetrapib 10 mg tablets daily from Days 1-17 plus atorvastatin calcium 80 mg tablets on Day -4 and Day 12 Receives: Drug: Obicetrapib; Drug: Atorvastatin Calcium |
| obicetrapib + rosuvastatin | Active comparator | Obicetrapib 10 mg tablets daily from Days 1-17 plus rosuvastatin calcium 40 mg tablets on Day -4 and Day 12 Receives: Drug: Obicetrapib; Drug: Rosuvastatin Calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure atorvastatin/rosuvastatin levels in the blood
Measure atorvastatin/rosuvastatin concentrations via various analytical methods
Measured: zero (0) to time of the last measurable analyte concentration (t), up to 22 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start11 Nov 2023
- Primary completion2 Dec 2023
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 74 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
- NCT06081166
- Sponsor's protocol ID
- TA-8995-11
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 22 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Kastelein JJP, Ditmarsch M, Hsieh A, Kling D, Walker A, Dicklin MR, Tayab Z, Bouhajib M, Davidson MH. A Drug-Drug Interaction Study Evaluating the Pharmacokinetic Consequences of Obicetrapib Therapy on Atorvastatin or Rosuvastatin Levels in Healthy Volunteers. Am J Cardiovasc Drugs. 2025 Sep;25(5):693-702. doi: 10.1007/s40256-025-00740-1. Epub 2025 Jun 26.
PubMed 40569335
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Atorvastatin Calcium Tablets or Rosuvastatin Calcium Tablets in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06081166
- Acronym / sponsor ID
- TA-8995-11
- Conditions
- Healthy Volunteers
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- NewAmsterdam PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Pharma Medica Research, Inc.
- Study start
- 11 Nov 2023 (actual)
- Primary completion
- 2 Dec 2023 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 13 Oct 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.
A study to evaluate impact of Obicetrapib on PK levels of Atorvastatin and Rosuvastatin
Detailed description
A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Atorvastatin Calcium Tablets or Rosuvastatin Calcium Tablets in Healthy Adult Subjects
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 + atorvastatin | Active comparator | Drug: Obicetrapib, Drug: Atorvastatin CalciumObicetrapib 10 mg tablets daily from Days 1-17 plus atorvastatin calcium 80 mg tablets on Day -4 and Day 12 |
| obicetrapib + rosuvastatin | Active comparator | Drug: Obicetrapib, Drug: Rosuvastatin CalciumObicetrapib 10 mg tablets daily from Days 1-17 plus rosuvastatin calcium 40 mg tablets on Day -4 and Day 12 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Cohort 1 Healthy, non-smoking, male and female subjects, from 18 to 65 years of age Cohort 2 Healthy, non-smoking, male and female subjects of non-Asian origin, from 18 to 65 years of age
- BMI ≥18.5 and ≤30 kg/m2
- Females may be of childbearing or non-childbearing potential:
- o Physically capable of becoming pregnant
- Willing to use acceptable, effective methods of contraception.
Key exclusion criteria (55 listed)
- Known history or presence 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.
- Known history or presence of hypersensitivity or idiosyncratic reaction to atorvastatin, rosuvastatin, obicetrapib, or any other drug substances with similar activity.
- Known history or presence of chronic infectious disease, system disorders, organ dysfunction especially hypothyroidism, stroke or transient ischemic attack, myopathy, rhabdomyolysis, renal or hepatic disorders, diabetes, or obesity which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- Known history or presence of clinically significant lactose, galactose, or fructose intolerance.
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 |
|---|---|---|
| ObicetrapibAlso: tabletsobicetrapib 10 mg daily | Drug | obicetrapib + atorvastatin, obicetrapib + rosuvastatin |
| Atorvastatin CalciumAlso: tabletsAtorvastatin 80 mg | Drug | obicetrapib + atorvastatin |
| Rosuvastatin CalciumAlso: tabletsRosuvastatin 40 mg | Drug | obicetrapib + rosuvastatin |
Primary outcome
Measure atorvastatin/rosuvastatin levels in the blood
Time frame: zero (0) to time of the last measurable analyte concentration (t), up to 22 days
Measure atorvastatin/rosuvastatin concentrations via various analytical methods
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 22 May 2025.
- Derived from this study: PubMed 40569335Kastelein JJP, Ditmarsch M, Hsieh A, Kling D, Walker A, Dicklin MR, Tayab Z, Bouhajib M, Davidson MH. A Drug-Drug Interaction Study Evaluating the Pharmacokinetic Consequences of Obicetrapib Therapy on Atorvastatin or Rosuvastatin Levels in Healthy Volunteers. Am J Cardiovasc Drugs. 2025 Sep;25(5):693-702. doi: 10.1007/s40256-025-00740-1. Epub 2025 Jun 26.
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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, Atorvastatin Calcium and Rosuvastatin Calcium 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 11 inclusion and 55 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 22 May 2025. 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?
Measure atorvastatin/rosuvastatin levels in the blood (time frame: zero (0) to time of the last measurable analyte concentration (t), up to 22 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06081166, which also lists 1 linked publication.
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 22 May 2025.