HypertensionPhase 1NCT05961384
Phase 1 Study to Determine the Metabolism and Clearance of Baxdrostat
A Phase 1 study testing baxdrostat in people with Hypertension, run by AstraZeneca at 1 site in United States.
Trial summary
This was a Phase 1, open-label, single dose study in healthy male subjects. The goals of this clinical trial were to determine how baxdrostat might be absorbed and metabolized using radioactive [14C] labeled baxdrostat. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy 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
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Nov 2021to 15 Jan 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
- Men only
- Healthy volunteers accepted
- Adult
Subjects must meet the following inclusion criteria:
- Be males of any race between 18 and 55 years of age
- Have a body mass index between 18.0 and 32.0 kg/m2
- Be in good health, determined by no clinically significant findings from medical history
- Have normal renal function, defined as estimated GFR ≥70 mL/min/1.73 m2
- Agree to use contraception
- Be able to comprehend and willing to sign an ICF and to abide by the study restrictions
- Have a history of a minimum of 1 bowel movement per day
- Agree to refrain from donation of sperm from check-in until 90 days after discharge
Main Exclusion Criteria:
- Significant history or clinical manifestation of any diseases as determined by the investigator
- Prolonged QTcF (>450 msec)
- Confirmed (eg, 2 consecutive measurements) systolic BP >140 or <90 mmHg, diastolic BP >90 or <50 mmHg, and pulse rate >100 or <45 beats per minute (bpm).
- Postural tachycardia (ie, >30 bpm upon standing) or orthostatic hypotension (ie, a fall in systolic BP of ≥20 mmHg or diastolic BP of ≥10 mmHg upon standing).
- Serum potassium >upper limit of normal (5.3 mmol/L; ULN) of the reference range and serum sodium <lower limit of normal (135 mmol/L) of the reference range
- Aspartate aminotransferase, alanine aminotransferase, or total bilirubin values >1.2 × ULN.
- A known history of porphyria, myopathy, or active liver disease
- Use of any prescription medications
- Corticosteroid use (systemic or extensive topical use) within 3 months prior to dosing
- Subjects who have participated in more than 3 radiolabeled drug studies in the last 12 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Labcorp Clinical Research Unit
Madison, Wisconsin, 53704
About this study
Official title: A Phase 1, Open-Label Study Of The Absorption, Metabolism, And Excretion Of [14C]-Baxdrostat Following A Single Oral Dose In Healthy Male Subjects
This was a Phase 1, open-label, single dose study in healthy male subjects. The goals of this clinical trial were to determine how baxdrostat might be absorbed and metabolized using radioactive [14C] labeled baxdrostat. Subjects were administered a single oral dose of 10 mg containing approximately 100 μCi of [14C] baxdrostat. Subjects were to be confined to the study site for 9 to 15 days for blood, urine, and feces collections.
- Conditions
- Hypertension
- Being tested
- baxdrostat
- Keywords
- pharmacokinetics (PK), metabolism, 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
a blood pressure lowering drug, oral dose
| Study group | Role | What they receive |
|---|---|---|
| 10 mg [14C]-bexdrostat | Experimental | single oral dose of 10 mg baxdrostat containing 100 μCi of [14C] baxdrostat Receives: Drug: baxdrostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total radioactivity recovery in urine and feces following administration of [14C] baxdrostat.
Measurement of total radioactivity recovery in urine and feces to determine the routes, rates of elimination, and mass balance of total radioactivity from [14C] baxdrostat.
Measured: 1 to 15 days after dosing
Area under the curve [AUC] of baxdrostat and its primary metabolite (CIN-107M) following administration of [14C] baxdrostat to healthy male subjects.
Area under the curve (AUC)0-∞ and AUC0-last will be determined for baxdrostat and CIN-107M in plasma.
Measured: 1 to 15 days after dosing
Cumulative baxdrostat and CIN-107M excreted in urine and fraction of baxdrostat renally excreted following administration of [14C] baxdrostat to healthy subjects.
Determining cumulative amount of baxdrostat and CIN-107M excreted in urine, clearance of baxdrostat and CIN-107M, and fraction of dose excreted renally (baxdrostat only).
Measured: 1 to 15 days after dosing
Maximum concentration [Cmax] for baxdrostat and CIN-107M in plasma.
Cmax will be determined based on measurement of baxdrostat and CIN-107M in plasma.
Measured: 1 to 15 days after dosing
Time to maximum concentration [Tmax] for baxdrostat and CIN-107M in plasma.
Tmax will be determined based on measurement of baxdrostat and CIN-107M in plasma.
Measured: 1 to 15 days after dosing
Terminal elimination half-life (t1/2) for baxdrostat and CIN-107M in plasma.
t1/2 for baxdrostat and CIN-107M in plasma will be determined based on measurement of baxdrostat and CIN-107M in plasma.
Measured: 1 to 15 days after dosing
Secondary outcomes (3)
Quantitative metabolic profiles of baxdrostat in plasma and excreta.
To determine, where possible, the quantitative metabolite profiles in plasma, urine, and feces after [14C]-baxdrostat
Measured: 1 to 15 days after dosing
Identification of baxdrostat metabolites in plasma and excreta.
To determine, where possible, the chemical structure of major metabolites in plasma, urine, and feces after [14C]-baxdrostat
Measured: 1 to 15 days after dosing
Incidence of treatment emergent adverse events following administration of [14C] baxdrostat.
Incidence of adverse events will be used to assess the safety and tolerability of [14C] baxdrostat when administered to healthy subjects.
Measured: 1 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 posted27 Jul 2023
- Study start18 Nov 2021
- Primary completion15 Jan 2022
- Study completion15 Jan 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicholas Siebers, MD Siebers, MD, Principal investigator, Labcorp Clinical Research Unit, Madison, Wisconsin, USA 53704
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05961384
- Sponsor's protocol ID
- CIN-107-117
- Status last verified
- Aug 2023
- First submitted
- 3 Jul 2023
- Last updated
- 15 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 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-Label Study Of The Absorption, Metabolism, And Excretion Of [14C]-Baxdrostat Following A Single Oral Dose In Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT05961384
- Acronym / sponsor ID
- CIN-107-117
- Conditions
- Hypertension
- Keywords
- pharmacokinetics (PK), metabolism, baxdrostat
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 15 Jan 2022 (actual)
- Study completion
- 15 Jan 2022 (actual)
- First posted
- 27 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.
This was a Phase 1, open-label, single dose study in healthy male subjects. The goals of this clinical trial were to determine how baxdrostat might be absorbed and metabolized using radioactive [14C] labeled baxdrostat. Subjects were administered a single oral dose of 10 mg containing approximately 100 μCi of [14C] baxdrostat. Subjects were to be confined to the study site for 9 to 15 days for blood, urine, and feces collections.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 10 mg [14C]-bexdrostat | Experimental | Drug: baxdrostatsingle oral dose of 10 mg baxdrostat containing 100 μCi of [14C] baxdrostat |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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-107a blood pressure lowering drug, oral dose | Drug | 10 mg [14C]-bexdrostat |
Primary outcome
Total radioactivity recovery in urine and feces following administration of [14C] baxdrostat.
Time frame: 1 to 15 days after dosing
Measurement of total radioactivity recovery in urine and feces to determine the routes, rates of elimination, and mass balance of total radioactivity from [14C] baxdrostat.
Area under the curve [AUC] of baxdrostat and its primary metabolite (CIN-107M) following administration of [14C] baxdrostat to healthy male subjects.
Time frame: 1 to 15 days after dosing
Area under the curve (AUC)0-∞ and AUC0-last will be determined for baxdrostat and CIN-107M in plasma.
Cumulative baxdrostat and CIN-107M excreted in urine and fraction of baxdrostat renally excreted following administration of [14C] baxdrostat to healthy subjects.
Time frame: 1 to 15 days after dosing
Determining cumulative amount of baxdrostat and CIN-107M excreted in urine, clearance of baxdrostat and CIN-107M, and fraction of dose excreted renally (baxdrostat only).
Maximum concentration [Cmax] for baxdrostat and CIN-107M in plasma.
Time frame: 1 to 15 days after dosing
Cmax will be determined based on measurement of baxdrostat and CIN-107M in plasma.
Time to maximum concentration [Tmax] for baxdrostat and CIN-107M in plasma.
Time frame: 1 to 15 days after dosing
Tmax will be determined based on measurement of baxdrostat and CIN-107M in plasma.
Terminal elimination half-life (t1/2) for baxdrostat and CIN-107M in plasma.
Time frame: 1 to 15 days after dosing
t1/2 for baxdrostat and CIN-107M in plasma will be determined based on measurement of baxdrostat and CIN-107M in plasma.
3 secondary outcomes
Quantitative metabolic profiles of baxdrostat in plasma and excreta.
Time frame: 1 to 15 days after dosing
Identification of baxdrostat metabolites in plasma and excreta.
Time frame: 1 to 15 days after dosing
Incidence of treatment emergent adverse events following administration of [14C] baxdrostat.
Time frame: 1 to 15 days after dosing
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 15 Aug 2023.
- CSR Synopsis RedactedLink 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.
Nicholas Siebers, MD Siebers, MD principal investigator
Labcorp Clinical Research Unit, Madison, Wisconsin, USA 53704
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?
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 15 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?
Total radioactivity recovery in urine and feces following administration of [14C] baxdrostat. (time frame: 1 to 15 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 15 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.