HypertensionPhase 1NCT05966324
Baxdrostat Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study in a Japanese Population
A Phase 1 study testing baxdrostat in people with Hypertension, run by AstraZeneca at 1 site in United States.
Trial summary
The goal of this study is to compare the characteristics of baxdrostat (CIN-107) in terms of baxdrostat levels over time in the blood in healthy Japanese and Caucasian volunteer participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- baxdrostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2022to 20 Sep 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
- Male or female subjects, 18 to 55 years of age, inclusive.
- Demographics as follows:
- Japanese subjects must have been born in Japan, with both biological parents and all 4 biological grandparents of Japanese descent, have lived outside of Japan for < 10 years, and have not significantly changed his or her diet since leaving Japan (eg, still mainly eating a "Japanese" diet), OR
- Caucasian ancestry (Cohort 3)
- Healthy status as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, and laboratory assessments (hematology, chemistry, serology, and urinalysis).
- A BMI between 18 - 30 kg/m2, inclusive.
Show all 9Show fewer
- Females may be of nonchildbearing or childbearing potential. Females of nonchildbearing potential are postmenopausal or surgically sterile. Females of nonchildbearing potential are exempt from the dual contraception requirement.
- Females of childbearing potential may be included, provided the subject agrees to continuously use dual methods of contraception from 1 month prior through 90 days after study drug administration.
- Able to participate and willing to give written informed consent and to comply with the study restrictions.
Who cannot join
- Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, allergic, ophthalmological disease or connective tissue disease, cancer or cirrhosis.
- A history of clinically significant drug hypersensitivity.
- Subjects with clinically significant symptoms of an infectious illness (bacterial, viral, or parasitic) within 5 days of the first dose or a history of recurrent infections.
- History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction (including soft drugs like cannabis products) within 6 months of screening.
- Nicotine users unable or unwilling to restrict nicotine usage to the equivalent of 5 cigarettes daily during the study and to not smoke during the in-clinic stays. (Nicotine-containing products include cigarettes, chewing tobacco, snuff, nicotine patches, electronic cigarettes, vaping devices, etc.)
- Positive result for HIV-1 or HIV-2, hepatitis C virus (HCV), or HBsAg at screening.
Show all 33Show fewer
- Confirmed (based on the average of ≥ 3 blood pressure measurements) sustained systolic blood pressure > 140 or < 90 mmHg, and diastolic blood pressure > 90 or < 45 mmHg, and pulse rate > 100 or < 40 bpm.
- Personal or family history of congenital long QT syndrome or QTcF values > 450 msec in males or > 470 msec in females.
- Screening or baseline ECGs with QRS and/or T-wave judged by the Investigator to be unfavorable for a consistently accurate QT measurement (ie, neuromuscular artifact that cannot be readily eliminated, arrhythmias, indistinct QRS onset, low amplitude T-wave, merged T- and U-waves, prominent U-waves, etc.)
- Screening or baseline ECG with clinically significant abnormalities such as atrial fibrillation, atrial flutter, complete bundle branch block, Wolf-Parkinson-White Syndrome, or cardiac pacemaker, as judged by the Investigator.
- Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel, and urinalysis) at screening or prior to dosing. The Medical Monitor may be consulted to discuss questionable abnormalities. Laboratory values that are not clinically significant, in the Investigator's opinion, may be allowable. In addition, subjects with the following will be excluded from the study (regardless of significance):
- red blood cell count < 0.75 x lower limit of normal (LLN)
- white blood cell count < 0.75 x LLN
- hemoglobin < 0.75 x LLN
- aspartate transaminase > 1.25 x upper limit of normal (ULN)
- alanine aminotransferase > 1.25 x ULN
- potassium > ULN
- sodium < LLN
- In case of questionable results, tests performed during screening or Day -2 may be repeated before dosing to confirm eligibility.
- Subjects with estimated glomerular filtration rate < 60 mL/min (according to the Modification of Diet in Renal Disease formula).
- Subjects with clinically significant orthostatic hypotension (defined as a decrease in systolic blood pressure of ≥ 20 mmHg or a decrease in diastolic blood pressure of ≥ 10 mmHg at 2 minutes of standing).
- Donation of blood > 450 mL within 3 months prior to screening or plasma within 14 days of dose administration.
- Concomitant disease or condition that could interfere with, or for which the treatment thereof, might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
- Known intolerance to cosyntropin test product.
- Use of prescription, over-the-counter, or herbal medications within 14 days prior to dose administration.
- Participation in an investigational drug or device study within 30 days or 5 half-lives, whichever is longer, prior to dosing.
- Corticosteroid use (systemic or extensive topical use) within 3 months prior to dosing.
- Has received a vaccination within 14 days prior to administration of the study drug.
- Males must agree to not donate sperm from screening through 90 days after study drug administration has been completed.
- Strenuous activity (as assessed by the Investigator) within 48 hours prior to clinical site admission.
- Consumption of alcohol or caffeine-containing food or beverages within 3 days prior to admission to the clinical site.
- Involved in the planning or conduct of this study.
- Unwilling or unlikely to comply with the requirements of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Single and Multiple Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Baxdrostat in Healthy Japanese and Caucasian Subjects
The goal of this study is to compare the characteristics of baxdrostat (CIN-107) in terms of baxdrostat levels over time in the blood in healthy Japanese and Caucasian volunteer participants.
Read the detailed description
Main Objectives were:
- To assess the safety and tolerability of single and multiple oral doses of baxdrostat in healthy Japanese subjects.
- To assess pharmacokinetics (PK) of baxdrostat and CIN-107-M after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
- To assess pharmacodynamic (PD) effects of single and multiple oral doses of baxdrostat in healthy Japanese subjects.
- To compare the PK and PD of baxdrostat and CIN-107-M after single and multiple oral doses of baxdrostat between Japanese and Caucasian subjects.
Participants will take baxdrostat and have their safety and blood levels of baxdrostat measured over several days following single and multiple dose administration of 3 different dose levels of baxdrostat. The baxdrostat blood levels over time and the levels of certain hormones that regulate blood pressure will be compared between the dose groups and between the healthy Japanese and Caucasian volunteer participants.
- Conditions
- Hypertension
- Being tested
- baxdrostat
- Keywords
- hypertension, Japanese, PK, baxdrostat
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baxdrostatDrug
Also called CIN-107
Baxdrostat is an aldosterone synthase inhibitor
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Oral tablet dose of baxdrostat 1 mg or placebo, administered as a single dose (Day 1) and multiple doses (once daily [QD] for 5 days, Days 6 - 10) to Japanese subjects Receives: Drug: baxdrostat |
| Cohort 2 | Experimental | Oral tablet dose of baxdrostat 3 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Japanese subjects Receives: Drug: baxdrostat |
| Cohort 3 | Experimental | Oral tablet dose of baxdrostat 3 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Caucasian subjects Receives: Drug: baxdrostat |
| Cohort 4 | Experimental | Oral tablet dose of baxdrostat 10 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Japanese subjects Receives: Drug: baxdrostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment emergent adverse events following single and multiple doses of baxdrostat in healthy Japanese and Caucasian participants versus placebo recipients.
Safety and tolerability will be assessed by comparison of number of treatment emergent adverse events between groups.
Measured: 0 to 19 days after dosing
Area under the curve (AUC) for baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
AUC [0 to 24 hours, 0 to last quantifiable concentration, and 0 to infinity of baxdrostat] will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Measured: 0 to 15 days after dosing
Maximum Plasma Concentration [Cmax] of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Cmax will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Measured: 0 to 15 days after dosing
Plasma aldosterone levels following single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Plasma aldosterone levels will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Measured: 0 to 15 days after dosing
Time to Maximum Plasma Concentration [Tmax] of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Tmax will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Measured: 0 to 15 days after dosing
Terminal elimination half-life of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Terminal elimination half-life will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Measured: 0 to 15 days after dosing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start5 Jul 2022
- Primary completion20 Sep 2022
- Study completion20 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Parallel groups
- Model description
- This was a single and multiple oral dose study of the safety/tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy Japanese subjects compared with a cohort of healthy Caucasian subjects. total of 41 subjects were enrolled in this study: 31 Japanese subjects and 10 Caucasian subjects. The study included 4 cohorts and each cohort consisted of 10 subjects, randomized 4:1 (active:placebo). The Japanese cohorts (Cohorts 1, 2, and 4) were performed in parallel. The Caucasian cohort (Cohort 3) was performed after Cohort 2 was complete so that the Caucasian subjects could be matched by certain demographic factors.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter J Winkle, MD, Principal investigator, ICON Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966324
- Sponsor's protocol ID
- CIN-107-126
- Status last verified
- Aug 2023
- First submitted
- 4 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Single and Multiple Dose Study to Assess the Safety, Pharmacokinetics, and Pharmacodynamics of Baxdrostat in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT05966324
- Acronym / sponsor ID
- CIN-107-126
- Conditions
- Hypertension
- Keywords
- hypertension, Japanese, PK, baxdrostat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 20 Sep 2022 (actual)
- First posted
- 28 Jul 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.
The goal of this study is to compare the characteristics of baxdrostat (CIN-107) in terms of baxdrostat levels over time in the blood in healthy Japanese and Caucasian volunteer participants.
Detailed description
Main Objectives were:
- To assess the safety and tolerability of single and multiple oral doses of baxdrostat in healthy Japanese subjects.
- To assess pharmacokinetics (PK) of baxdrostat and CIN-107-M after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
- To assess pharmacodynamic (PD) effects of single and multiple oral doses of baxdrostat in healthy Japanese subjects.
- To compare the PK and PD of baxdrostat and CIN-107-M after single and multiple oral doses of baxdrostat between Japanese and Caucasian subjects.
Participants will take baxdrostat and have their safety and blood levels of baxdrostat measured over several days following single and multiple dose administration of 3 different dose levels of baxdrostat. The baxdrostat blood levels over time and the levels of certain hormones that regulate blood pressure will be compared between the dose groups and between the healthy Japanese and Caucasian volunteer participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- This was a single and multiple oral dose study of the safety/tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) in healthy Japanese subjects compared with a cohort of healthy Caucasian subjects. total of 41 subjects were enrolled in this study: 31 Japanese subjects and 10 Caucasian subjects. The study included 4 cohorts and each cohort consisted of 10 subjects, randomized 4:1 (active:placebo). The Japanese cohorts (Cohorts 1, 2, and 4) were performed in parallel. The Caucasian cohort (Cohort 3) was performed after Cohort 2 was complete so that the Caucasian subjects could be matched by certain demographic factors.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: baxdrostatOral tablet dose of baxdrostat 1 mg or placebo, administered as a single dose (Day 1) and multiple doses (once daily [QD] for 5 days, Days 6 - 10) to Japanese subjects |
| Cohort 2 | Experimental | Drug: baxdrostatOral tablet dose of baxdrostat 3 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Japanese subjects |
| Cohort 3 | Experimental | Drug: baxdrostatOral tablet dose of baxdrostat 3 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Caucasian subjects |
| Cohort 4 | Experimental | Drug: baxdrostatOral tablet dose of baxdrostat 10 mg or placebo, administered as a single dose (Day 1) and multiple doses (QD for 5 days, Days 6 - 10) to Japanese subjects |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female subjects, 18 to 55 years of age, inclusive.
- Demographics as follows:
- Healthy status as defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, 12-lead ECG, and laboratory assessments (hematology, chemistry, serology, and urinalysis).
- A BMI between 18 - 30 kg/m2, inclusive.
- Females may be of nonchildbearing or childbearing potential. Females of nonchildbearing potential are postmenopausal or surgically sterile. Females of nonchildbearing potential are exempt from the dual contraception requirement.
Key exclusion criteria (33 listed)
- Any clinically relevant history or the presence of respiratory, renal, hepatic, gastrointestinal, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, allergic, ophthalmological disease or connective tissue disease, cancer or cirrhosis.
- A history of clinically significant drug hypersensitivity.
- Subjects with clinically significant symptoms of an infectious illness (bacterial, viral, or parasitic) within 5 days of the first dose or a history of recurrent infections.
- History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse or addiction (including soft drugs like cannabis products) within 6 months of screening.
- Nicotine users unable or unwilling to restrict nicotine usage to the equivalent of 5 cigarettes daily during the study and to not smoke during the in-clinic stays. (Nicotine-containing products include cigarettes, chewing tobacco, snuff, nicotine patches, electronic cigarettes, vaping devices, etc.)
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 |
|---|---|---|
| baxdrostatAlso: CIN-107Baxdrostat is an aldosterone synthase inhibitor | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Incidence of treatment emergent adverse events following single and multiple doses of baxdrostat in healthy Japanese and Caucasian participants versus placebo recipients.
Time frame: 0 to 19 days after dosing
Safety and tolerability will be assessed by comparison of number of treatment emergent adverse events between groups.
Area under the curve (AUC) for baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Time frame: 0 to 15 days after dosing
AUC [0 to 24 hours, 0 to last quantifiable concentration, and 0 to infinity of baxdrostat] will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Maximum Plasma Concentration [Cmax] of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Time frame: 0 to 15 days after dosing
Cmax will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Plasma aldosterone levels following single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Time frame: 0 to 15 days after dosing
Plasma aldosterone levels will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Time to Maximum Plasma Concentration [Tmax] of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Time frame: 0 to 15 days after dosing
Tmax will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
Terminal elimination half-life of baxdrostat and the CIN-107-M metabolite after single and multiple oral doses of baxdrostat in healthy Japanese subjects.
Time frame: 0 to 15 days after dosing
Terminal elimination half-life will be determined for baxdrostat and the CIN-107M metabolite for Japanese participants in each of each of the 3 dose groups of baxdrostat.
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 Aug 2023.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
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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.
Peter J Winkle, MD principal investigator
ICON Clinical Research
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 baxdrostat in people with Hypertension, run by AstraZeneca 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 9 inclusion and 33 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 Aug 2023. 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?
Incidence of treatment emergent adverse events following single and multiple doses of baxdrostat in healthy Japanese and Caucasian participants versus placebo recipients. (time frame: 0 to 19 days after dosing). The study lists 6 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 Aug 2023.