Hepatic ImpairmentPhase 1NCT06048302
PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function
A Phase 1 study testing Obicetrapib in people with Hepatic Impairment and Healthy, run by NewAmsterdam Pharma at 2 sites in United States.
Trial summary
To investigate the safety and pharmacokinetics in patients with moderate hepatic impairment compared to healthy participants after a single oral dose of obicetrapib (10 mg). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatic Impairment, Healthy
- What is being tested?
- Obicetrapib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2023to 19 Mar 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A male or a female of non-childbearing potential.
- Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at the Screening Visit.
- Body mass index (BMI) of 17.5 to 42 kg/m2; with a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
- Cohort 1: Meet the criteria for Class B (moderate hepatic impairment) of the modified CPC. A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination (PE), liver biopsy, hepatic ultrasound, computerized tomography scan, or magnetic resonance imaging.
- Cohort 2: Will only enroll healthy volunteers with no hepatic impairment. "Healthy" is defined as no clinically relevant abnormalities identified by a detailed medical history, complete PE (including blood pressure [BP] and pulse rate measurement), 12-lead ECG or clinical laboratory tests performed during Screening.
Who cannot join
- Any condition possibly affecting drug absorption (e.g., gastrectomy). Uncomplicated cholecystectomy is allowed.
- History of or current positive results for human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) or hepatitis C virus (HCV), including hepatitis B surface antigen (HbsAg) or hepatitis C Virus antibody (HCVAb).
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the Investigator's judgment, make the participant inappropriate for participation in the study.
- Participants with an estimated glomerular filtration rate (eGFR) value of ≤30 mL/min/1.73 m2, based on the 2021 Chronic Kidney Disease Epidemiology Collaboration equation during Screening. A single repeat assessment is permitted to assess eligibility, if needed.
- Previous administration of drugs or supplements known to be strong inducers or inhibitors of CYP3A4 within 7 days of planned dosing of obicetrapib on Day 1.
- Concurrent use of drugs or supplements that are known substrates of CYP3A that have narrow therapeutic indices (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl including transdermal patch, pimozide, quinidine, sirolimus, tacrolimus) within 12 days prior to planned dosing of obicetrapib on Day 1.
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- Participants on oral contraceptives and hormonal based contraceptives including implantable, intrauterine, intravaginal, transdermal or injectable form.
- Previous administration of an investigational drug within 30 days (or as determined by the local requirement) or within 5 half-lives of that investigational drug, prior to planned dosing of obicetrapib on Day 1.
- Known hypersensitivity to obicetrapib or its excipients.
- A positive urine drug test. Participants with moderate hepatic impairment (Cohort 1) will be eligible to participate if their urine drug test is positive with a drug for a prescribed condition that is not expected to interfere with the PK of obicetrapib. Positive urine drug tests for tetrahydrocannabinol (THC) will be allowed as long as the volunteer agrees to abstain from ingesting any THC-containing products for the duration of the study (including Out patient visits up to Day 28).
- Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to planned dosing of obicetrapib on Day 1.
- History of sensitivity to heparin or a history of heparin-induced thrombocytopenia.
- Unwilling or unable to comply with the criteria in the Lifestyle considerations listed in the protocol.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Nucleus Network
Saint Paul, Minnesota, 55114
The American Research Corporation
San Antonio, Texas, 78215
About this study
Official title: A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Plasma Pharmacokinetics and Safety of Obicetrapib in Participants With Moderate Hepatic Impairment Relative to Participants With Normal Hepatic Function
To investigate the safety and pharmacokinetics in patients with moderate hepatic impairment compared to healthy participants after a single oral dose of obicetrapib (10 mg).
Read the detailed description
This is a Phase 1, open-label, single-dose, parallel-group study to evaluate the plasma PK and safety of obicetrapib in participants with moderate hepatic impairment relative to participants with normal hepatic function. The purpose of the study is to investigate the effect of moderate hepatic impairment on obicetrapib PK and safety in otherwise healthy participants after a single oral 10 mg dose of obicetrapib.
- Conditions
- Hepatic Impairment, Healthy
- Being tested
- Obicetrapib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObicetrapibDrug
Also called 10 mg tablet
1 single dose of obicetrapib
| Study group | Role | What they receive |
|---|---|---|
| Active Comparitor: Subjects with Moderate Hepatic Impairment | Active comparator | 8 patients with hepatic impairment of moderate Child Pugh Category Receives: Drug: Obicetrapib |
| Active Comparator: Healthy Subjects | Other | Healthy volunteers will be matched with impaired hepatic function patients Receives: Drug: Obicetrapib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the curve from dosing time to infinity (AUC (0-inf)) for obicetrapib
Blood samples collected
Measured: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
Area under curve from dosing time to last measurement (AUC (0-t)) for obicetrapib
Blood Sample Collected
Measured: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
Observed maximum plasma concentration (Cmax) for Obicetrapib
Blood Sample Collected
Measured: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start30 Nov 2023
- Primary completion12 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic ImpairmentStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase 1, open-label, single-dose, parallel-group study to evaluate the plasma PK and safety of obicetrapib in participants with moderate hepatic impairment relative to participants with normal hepatic function. The purpose of the study is to investigate the effect of moderate hepatic impairment on obicetrapib PK and safety in otherwise healthy participants after a single oral 10 mg dose of obicetrapib.
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- NewAmsterdam Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Veranex
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06048302
- Sponsor's protocol ID
- TA-8995-12
- Status last verified
- Sep 2024
- First submitted
- 29 Aug 2023
- Last updated
- 19 Sep 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Single-dose, Parallel-group Study to Evaluate the Plasma Pharmacokinetics and Safety of Obicetrapib in Participants With Moderate Hepatic Impairment Relative to Participants With Normal Hepatic Function
- ClinicalTrials.gov ID
- NCT06048302
- Acronym / sponsor ID
- TA-8995-12
- Conditions
- Hepatic Impairment, Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- NewAmsterdam PharmaIndustry (pharma, biotech, devices)
- Collaborators
- Veranex
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 12 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 21 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.
To investigate the safety and pharmacokinetics in patients with moderate hepatic impairment compared to healthy participants after a single oral dose of obicetrapib (10 mg).
Detailed description
This is a Phase 1, open-label, single-dose, parallel-group study to evaluate the plasma PK and safety of obicetrapib in participants with moderate hepatic impairment relative to participants with normal hepatic function. The purpose of the study is to investigate the effect of moderate hepatic impairment on obicetrapib PK and safety in otherwise healthy participants after a single oral 10 mg dose of obicetrapib.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Phase 1, open-label, single-dose, parallel-group study to evaluate the plasma PK and safety of obicetrapib in participants with moderate hepatic impairment relative to participants with normal hepatic function. The purpose of the study is to investigate the effect of moderate hepatic impairment on obicetrapib PK and safety in otherwise healthy participants after a single oral 10 mg dose of obicetrapib.
| Arm | Type | Receives |
|---|---|---|
| Active Comparitor: Subjects with Moderate Hepatic Impairment | Active comparator | Drug: Obicetrapib8 patients with hepatic impairment of moderate Child Pugh Category |
| Active Comparator: Healthy Subjects | Other | Drug: ObicetrapibHealthy volunteers will be matched with impaired hepatic function patients |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- A male or a female of non-childbearing potential.
- Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at the Screening Visit.
- Body mass index (BMI) of 17.5 to 42 kg/m2; with a total body weight >50 kg (110 lb).
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
Key exclusion criteria (13 listed)
- Any condition possibly affecting drug absorption (e.g., gastrectomy). Uncomplicated cholecystectomy is allowed.
- History of or current positive results for human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) or hepatitis C virus (HCV), including hepatitis B surface antigen (HbsAg) or hepatitis C Virus antibody (HCVAb).
- Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the Investigator's judgment, make the participant inappropriate for participation in the study.
- Participants with an estimated glomerular filtration rate (eGFR) value of ≤30 mL/min/1.73 m2, based on the 2021 Chronic Kidney Disease Epidemiology Collaboration equation during Screening. A single repeat assessment is permitted to assess eligibility, if needed.
- Previous administration of drugs or supplements known to be strong inducers or inhibitors of CYP3A4 within 7 days of planned dosing of obicetrapib on Day 1.
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: 10 mg tablet1 single dose of obicetrapib | Drug | Active Comparator: Healthy Subjects, Active Comparitor: Subjects with Moderate Hepatic Impairment |
Primary outcome
Area under the curve from dosing time to infinity (AUC (0-inf)) for obicetrapib
Time frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
Blood samples collected
Area under curve from dosing time to last measurement (AUC (0-t)) for obicetrapib
Time frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
Blood Sample Collected
Observed maximum plasma concentration (Cmax) for Obicetrapib
Time frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
Blood Sample Collected
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 19 Sep 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.
2 sites 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 in people with Hepatic Impairment and Healthy, run by NewAmsterdam Pharma at 2 sites 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 13 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Area under the curve from dosing time to infinity (AUC (0-inf)) for obicetrapib (time frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168). 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 19 Sep 2024.