HypertensionPhase 1NCT05963009
Baxdrostat Bioavailability and Bioequivalence Study
A Phase 1 study testing baxdrostat (formerly CIN-107) oral solution in people with Hypertension, run by AstraZeneca at 1 site in United States.
Trial summary
The goal of this study was to compare the characteristics of a new tablet formulation versus an oral solution of CIN-107 (baxdrostat) in terms of CIN-107 levels over time in the blood and to compare the effect of food on these parameters in healthy volunteer participants who received the CIN-107 tablet under fed… 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 (formerly CIN-107) oral solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Mar 2020to 29 Apr 2020
- 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
- Healthy subjects between the ages of 18 and 55 years, inclusive, in good health based on medical and psychiatric history, physical examination, electrocardiogram (ECG), vital signs (seated and orthostatic), and routine laboratory tests (blood chemistry, hematology, coagulation, and urinalysis).
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
- Nonsmokers who have not used nicotine-containing products for at least 6 months prior to Screening.
- Male subjects with female partners of child-bearing potential must agree to use two medically accepted, highly effective methods of birth control from Day 1 through 90 days after the final dose of study drug.
- Male subjects must agree to abstain from sperm donation from Day 1 through 90 days after administration of the final dose of study drug.
- Female subjects with male partners must be surgically sterile (hysterectomy and/or bilateral oophorectomy), postmenopausal for at least 1 year (with follicle-stimulating hormone in postmenopausal range), or agree to use two medically accepted, highly effective methods of birth control from Day -14 until 60 days following the final dose of study drug.
- Able to understand and willing to comply with study procedures and restrictions (including confinement to the clinical unit, fasting and meal requirements, and restrictions on physical activity, use of recreational drugs or alcohol, and medications), and provide written informed consent according to institutional and regulatory guidelines.
Who cannot join
- Actively participating in an experimental therapy study; received experimental therapy with a small molecule other than CIN-107 within 30 days of the first dose of study drug, or 5 halflives, whichever is longer; or received experimental therapy with a large molecule within 90 days of the first dose of study drug, or 5 half-lives, whichever is longer.
- A personal or family history of long QT syndrome, Torsades de Pointes, or other complex ventricular arrhythmias, or family history of sudden death.
- History of, or current, clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, atrial fibrillation, sinus node dysfunction, or clinically significant heart block. Subjects with minor forms of ectopy (eg, premature atrial contractions) are not necessarily excluded.
- Prolonged QTcF (>450 msec).
- Seated blood pressure higher than 150/90 mmHg or lower than 90/50.
- Resting heart rate higher than 100 bpm or lower than 50 bpm.
Show all 26Show fewer
- Temperature (T) greater than 37.6 C (99.68 F), measured orally, and respiration rate less than 12 or greater than 20 breaths/minute.
- Postural tachycardia (i.e. >30 bpm upon standing) or orthostatic hypotension (i.e., a fall in systolic blood pressure (SBP) of ≥20 mm Hg or diastolic blood pressure (DBP) of ≥ 10 mm Hg when a person assumes a standing position).
- Serum potassium > upper limit of normal of the reference range (ULN) and serum sodium < lower limit of normal of the reference range (LLN).
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values > 1.2 ULN.
- Positive for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody, or Hepatitis B surface antigen (HBsAg).
- Any other clinical laboratory values which are meaningfully outside of normal limits (based on laboratory normal range) in the opinion of the Investigator.
- A known history of porphyria, myopathy, or an active liver disease.
- Evidence or history of any clinically significant immunologic, hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, musculoskeletal, hepatic, psychiatric, neurologic, or allergic disease (including clinically significant or multiple drug allergies); surgical conditions; cancer (with the exception of basal or squamous cell carcinoma of the skin and cancer that resolved or has been in remission for >5 years prior to Screening); or any condition that, in the Investigator's opinion, may confound study procedures or results, impact subject safety, or interfere with the absorption, distribution, metabolism, or excretion of the study drug (appendectomy allowed, cholecystectomy prohibited).
- Use of any prescription medications (including topicals) or over-the-counter medications (other than occasional use of acetaminophen or nonsteroidal anti-inflammatory drugs, such as ibuprofen or naproxen, according to the package insert); herbal supplements; dietary supplements; or nutraceuticals within 14 days prior to the first dose of study drug, or 5 halflives, whichever is longer, or an unwillingness to refrain from these medications through discharge from the clinical unit. Note: Use of over-the-counter topical medications may be permitted in consultation with the Sponsor. In addition, medications for which 5 half-lives exceeds 14 days must be discussed with and approved by the Sponsor prior to subject enrollment.
- Corticosteroid use (systemic or extensive topical) within 3 months prior to dosing.
- Positive drug or alcohol test result or a history of alcoholism or drug abuse within 2 years prior to the first dose of study drug as defined by the Diagnostic and Statistical Manual (DSM) of Mental Disorders, 4th Edition: DSM-IV.
- Typical consumption of ≥14 alcoholic drinks weekly. Note: 1 drink of alcohol is equivalent to ½ pint of beer (285 mL), 1 glass of spirits (25 mL), or 1 glass of wine (125 mL).
- History of or evidence of illicit drug use within the past 2 years.
- Surgical procedures within 4 weeks of check-in or planned elective surgery during the study period.
- Any illness during the 4 weeks before check-in, unless deemed not clinically significant by the Investigator.
- Known allergy to any ingredient of the study drug. Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
- Inadequate venous access.
- Currently undergoing treatment with weight loss medication or prior weight loss surgery (e.g., gastric bypass surgery).
- Pregnant, breastfeeding, or planning to become pregnant during the study.
- Considered by the Investigator, after reviewing medical and psychiatric history, physical examination, and laboratory evaluation, to be unsuitable for any other reason that may either place the subject at increased risk during participation or interfere with the interpretation of the study outcomes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Open Label, Crossover Study to Evaluate the Relative Bioavailability of a New Tablet Formulation of CIN-107 as Compared to Oral Solution and to Assess the Effect of Food on the CIN-107 Tablet Formulation in Healthy Subjects
The goal of this study was to compare the characteristics of a new tablet formulation versus an oral solution of CIN-107 (baxdrostat) in terms of CIN-107 levels over time in the blood and to compare the effect of food on these parameters in healthy volunteer participants who received the CIN-107 tablet under fed versus fasted conditions.
Read the detailed description
The goals of this study were to:
- To assess the safety and tolerability of single doses of CIN-107 tablet and oral solution in healthy participants.
- Compare CIN-107 levels over time in the blood in participants after dosing between a tablet formulation of CIN-107 as compared to the oral solution.
- Compare the CIN-107 levels over time in the blood in participants following dosing with a CIN-107 tablet after a meal versus in the fasted state.
Participants took either the oral solution or a tablet of CIN-107 and had their safety and blood levels of CIN-107 measured over several days following administration of CIN-107 tablet either in the fasted state or after a meal. The CIN-107 blood levels over time were compared between the groups given either the oral solution or the tablet and between the group given the CIN-107 tablet with a meal versus in the fasted state.
- Conditions
- Hypertension
- Being tested
- baxdrostat (formerly CIN-107) oral solution
- Keywords
- pharmacokinetics (PK), food effect, bioavailability
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
baxdrostat (formerly CIN-107) oral solutionDrug
Also called baxdrostat (formerly CIN-107) tablet
5 mg single dose of baxdrostat given as either a solution or tablet in either the fed or fasted state, depending on the arm of the study
| Study group | Role | What they receive |
|---|---|---|
| Baxdrostat oral solution | Experimental | 5 mg CIN-107 oral solution in a fasted state Receives: Drug: baxdrostat (formerly CIN-107) oral solution |
| Baxdrostat tablet (fasted state) | Experimental | 5 mg CIN-107 tablet(s) in a fasted state Receives: Drug: baxdrostat (formerly CIN-107) oral solution |
| Baxdrostat tablet (fed state) | Experimental | 5 mg CIN-107 tablet(s) in a fed state (standard high fat meal) Receives: Drug: baxdrostat (formerly CIN-107) oral solution |
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 oral doses of CIN-107 tablet and oral solution.
The safety and tolerability of CIN-107 will be assessed throughout the study based on quantitation of adverse events that occur following oral doses of CIN-107 tablet and oral solution.
Measured: 0 to 23 days after dosing
Maximum concentration [Cmax] following administration of a tablet formulation of CIN-107 compared to Cmax following administration of the oral solution.
Cmax will be determined for CIN-107 and any other measured metabolites for participants given each formulation of baxdrostat; relative bioavailability will be evaluated by comparing these parameters between patients given the solution versus the tablet.
Measured: 0 to 21 days after dosing
Cmax of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
Cmax will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions; food effect will be evaluated by comparing Cmax between participants under each condition.
Measured: 0 to 21 days after dosing
Area under the curve [AUC] following administration of a tablet formulation of CIN-107 compared to AUC following administration of the oral solution.
Area under the curve (AUC)0-∞ and AUC0-last will be determined for baxdrostat and any other measured metabolites for participants given each formulation of baxdrostat. Then relative bioavailability will be evaluated by comparing these AUC parameters between patients given the solution versus the tablet.
Measured: 0 to 21 days after dosing
Time to maximum concentration [Tmax] of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
Tmax will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions, and then food effect will be evaluated by comparing Tmax between participants under each condition.
Measured: 0 to 21 days after dosing
AUC of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
Area under the curve (AUC)0-∞ and AUC0-last will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions, and then food effect will be evaluated by comparing AUC between participants under each condition.
Measured: 0 to 21 days after dosing
Tmax following administration of a tablet formulation of CIN-107 compared to Tmax following administration of the oral solution.
Tmax will be determined for CIN-107 and any other measured metabolites for participants given each formulation of baxdrostat.
Measured: 0 to 21 days after dosing
Secondary outcomes (1)
Angiotensin converting enzyme (ACE) levels following single doses of CIN-107.
An exploratory assessment of the effect of CIN-107 on various measures associated with the Renin-Angiotensin-Aldosterone system including, but not limited to, angiotensin converting enzyme (ACE).
Measured: 0 to 21 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 start11 Mar 2020
- Primary completion29 Apr 2020
- Study completion29 Apr 2020
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
- Crossover
- Model description
- Randomized Crossover between 1) oral solution, 2) tablet in the fasted state, and 3) tablet in the fed state
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- L Vrishabhendra, MD, Principal investigator, Medpace, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05963009
- Sponsor's protocol ID
- CIN-107-112
- Status last verified
- Aug 2023
- First submitted
- 3 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
- Randomized, Open Label, Crossover Study to Evaluate the Relative Bioavailability of a New Tablet Formulation of CIN-107 as Compared to Oral Solution and to Assess the Effect of Food on the CIN-107 Tablet Formulation in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05963009
- Acronym / sponsor ID
- CIN-107-112
- Conditions
- Hypertension
- Keywords
- pharmacokinetics (PK), food effect, bioavailability
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 29 Apr 2020 (actual)
- Study completion
- 29 Apr 2020 (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.
The goal of this study was to compare the characteristics of a new tablet formulation versus an oral solution of CIN-107 (baxdrostat) in terms of CIN-107 levels over time in the blood and to compare the effect of food on these parameters in healthy volunteer participants who received the CIN-107 tablet under fed versus fasted conditions.
Detailed description
The goals of this study were to:
- To assess the safety and tolerability of single doses of CIN-107 tablet and oral solution in healthy participants.
- Compare CIN-107 levels over time in the blood in participants after dosing between a tablet formulation of CIN-107 as compared to the oral solution.
- Compare the CIN-107 levels over time in the blood in participants following dosing with a CIN-107 tablet after a meal versus in the fasted state.
Participants took either the oral solution or a tablet of CIN-107 and had their safety and blood levels of CIN-107 measured over several days following administration of CIN-107 tablet either in the fasted state or after a meal. The CIN-107 blood levels over time were compared between the groups given either the oral solution or the tablet and between the group given the CIN-107 tablet with a meal versus in the fasted state.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Randomized Crossover between 1) oral solution, 2) tablet in the fasted state, and 3) tablet in the fed state
| Arm | Type | Receives |
|---|---|---|
| Baxdrostat oral solution | Experimental | Drug: baxdrostat (formerly CIN-107) oral solution5 mg CIN-107 oral solution in a fasted state |
| Baxdrostat tablet (fasted state) | Experimental | Drug: baxdrostat (formerly CIN-107) oral solution5 mg CIN-107 tablet(s) in a fasted state |
| Baxdrostat tablet (fed state) | Experimental | Drug: baxdrostat (formerly CIN-107) oral solution5 mg CIN-107 tablet(s) in a fed state (standard high fat meal) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy subjects between the ages of 18 and 55 years, inclusive, in good health based on medical and psychiatric history, physical examination, electrocardiogram (ECG), vital signs (seated and orthostatic), and routine laboratory tests (blood chemistry, hematology, coagulation, and urinalysis).
- Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
- Nonsmokers who have not used nicotine-containing products for at least 6 months prior to Screening.
- Male subjects with female partners of child-bearing potential must agree to use two medically accepted, highly effective methods of birth control from Day 1 through 90 days after the final dose of study drug.
- Male subjects must agree to abstain from sperm donation from Day 1 through 90 days after administration of the final dose of study drug.
Key exclusion criteria (26 listed)
- Actively participating in an experimental therapy study; received experimental therapy with a small molecule other than CIN-107 within 30 days of the first dose of study drug, or 5 halflives, whichever is longer; or received experimental therapy with a large molecule within 90 days of the first dose of study drug, or 5 half-lives, whichever is longer.
- A personal or family history of long QT syndrome, Torsades de Pointes, or other complex ventricular arrhythmias, or family history of sudden death.
- History of, or current, clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, atrial fibrillation, sinus node dysfunction, or clinically significant heart block. Subjects with minor forms of ectopy (eg, premature atrial contractions) are not necessarily excluded.
- Prolonged QTcF (>450 msec).
- Seated blood pressure higher than 150/90 mmHg or lower than 90/50.
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 |
|---|---|---|
| baxdrostat (formerly CIN-107) oral solutionAlso: baxdrostat (formerly CIN-107) tablet5 mg single dose of baxdrostat given as either a solution or tablet in either the fed or fasted state, depending on the arm of the study | Drug | Baxdrostat oral solution, Baxdrostat tablet (fasted state), Baxdrostat tablet (fed state) |
Primary outcome
Incidence of treatment emergent adverse events following single oral doses of CIN-107 tablet and oral solution.
Time frame: 0 to 23 days after dosing
The safety and tolerability of CIN-107 will be assessed throughout the study based on quantitation of adverse events that occur following oral doses of CIN-107 tablet and oral solution.
Maximum concentration [Cmax] following administration of a tablet formulation of CIN-107 compared to Cmax following administration of the oral solution.
Time frame: 0 to 21 days after dosing
Cmax will be determined for CIN-107 and any other measured metabolites for participants given each formulation of baxdrostat; relative bioavailability will be evaluated by comparing these parameters between patients given the solution versus the tablet.
Cmax of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
Time frame: 0 to 21 days after dosing
Cmax will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions; food effect will be evaluated by comparing Cmax between participants under each condition.
Area under the curve [AUC] following administration of a tablet formulation of CIN-107 compared to AUC following administration of the oral solution.
Time frame: 0 to 21 days after dosing
Area under the curve (AUC)0-∞ and AUC0-last will be determined for baxdrostat and any other measured metabolites for participants given each formulation of baxdrostat. Then relative bioavailability will be evaluated by comparing these AUC parameters between patients given the solution versus the tablet.
Time to maximum concentration [Tmax] of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
Time frame: 0 to 21 days after dosing
Tmax will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions, and then food effect will be evaluated by comparing Tmax between participants under each condition.
AUC of CIN-107 following administration of the tablet formulation under fed versus fasted conditions.
Time frame: 0 to 21 days after dosing
Area under the curve (AUC)0-∞ and AUC0-last will be determined for CIN-107 and any other measured metabolites for participants given baxdrostat under fed versus fasted conditions, and then food effect will be evaluated by comparing AUC between participants under each condition.
Tmax following administration of a tablet formulation of CIN-107 compared to Tmax following administration of the oral solution.
Time frame: 0 to 21 days after dosing
Tmax will be determined for CIN-107 and any other measured metabolites for participants given each formulation of baxdrostat.
1 secondary outcome
Angiotensin converting enzyme (ACE) levels following single doses of CIN-107.
Time frame: 0 to 21 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 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.
L Vrishabhendra, MD principal investigator
Medpace, 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 baxdrostat (formerly CIN-107) oral solution 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 7 inclusion and 26 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 oral doses of CIN-107 tablet and oral solution. (time frame: 0 to 23 days after dosing). The study lists 7 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.