ClinicalTrials.gg
CompletedNCT05963009Updated Aug 14, 2023

Baxdrostat Bioavailability and Bioequivalence Study

A Phase 1 interventional study of baxdrostat (formerly CIN-107) oral solution in Hypertension, sponsored by AstraZeneca. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-14.

Sponsored by AstraZeneca · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was Apr 2020, 6 years 5 months ago, and no results have been posted to the registry.
  • Registered 3 years 3 months after the study started (first participant enrolled Mar 2020, registered Jul 2023).
Phase
Phase 1
Study type
Interventional
Enrollment
14
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
01

Study 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 versus fasted conditions.

Read the detailed description

The goals of this study were to:

  1. To assess the safety and tolerability of single doses of CIN-107 tablet and oral solution in healthy participants.
  2. 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.
  3. 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.

02

Conditions studied

  • Hypertension

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Keywords

  • pharmacokinetics (PK)
  • food effect
  • bioavailability
03

In context

Hypertension

6,834 studies on the registry are indexed under Hypertension; 971 are open to participants now.

This study's enrollment of 14 is below the median of 90 across 5,095 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,492 studies on the registry; 266 are open to participants now.

Of its 368 completed or terminated interventional studies of FDA-regulated products, 176 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. 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).
  2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
  3. Nonsmokers who have not used nicotine-containing products for at least 6 months prior to Screening.
  4. 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.
  5. Male subjects must agree to abstain from sperm donation from Day 1 through 90 days after administration of the final dose of study drug.
  6. 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.
  7. 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.

Exclusion criteria

Exclusion Criteria:

  1. 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.
  2. A personal or family history of long QT syndrome, Torsades de Pointes, or other complex ventricular arrhythmias, or family history of sudden death.
  3. 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.
  4. Prolonged QTcF (>450 msec).
  5. Seated blood pressure higher than 150/90 mmHg or lower than 90/50.
  6. Resting heart rate higher than 100 bpm or lower than 50 bpm.
  7. Temperature (T) greater than 37.6 C (99.68 F), measured orally, and respiration rate less than 12 or greater than 20 breaths/minute.
  8. 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).
  9. Serum potassium > upper limit of normal of the reference range (ULN) and serum sodium \< lower limit of normal of the reference range (LLN).
  10. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values > 1.2 ULN.
  11. Positive for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody, or Hepatitis B surface antigen (HBsAg).
  12. Any other clinical laboratory values which are meaningfully outside of normal limits (based on laboratory normal range) in the opinion of the Investigator.
  13. A known history of porphyria, myopathy, or an active liver disease.
  14. 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).
  15. 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.
  16. Corticosteroid use (systemic or extensive topical) within 3 months prior to dosing.
  17. 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.
  18. 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).
  19. History of or evidence of illicit drug use within the past 2 years.
  20. Surgical procedures within 4 weeks of check-in or planned elective surgery during the study period.
  21. Any illness during the 4 weeks before check-in, unless deemed not clinically significant by the Investigator.
  22. Known allergy to any ingredient of the study drug. Any history of severe allergic reaction (including drugs, food, insect bites, environmental allergens).
  23. Inadequate venous access.
  24. Currently undergoing treatment with weight loss medication or prior weight loss surgery (e.g., gastric bypass surgery).
  25. Pregnant, breastfeeding, or planning to become pregnant during the study.
  26. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
14 participants (actual)

Study arms

  • Experimental
    Baxdrostat oral solution

    5 mg CIN-107 oral solution in a fasted state

    Drug: baxdrostat (formerly CIN-107) oral solution

  • Experimental
    Baxdrostat tablet (fasted state)

    5 mg CIN-107 tablet(s) in a fasted state

    Drug: baxdrostat (formerly CIN-107) oral solution

  • Experimental
    Baxdrostat tablet (fed state)

    5 mg CIN-107 tablet(s) in a fed state (standard high fat meal)

    Drug: baxdrostat (formerly CIN-107) oral solution

Interventions

  • 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

    Also known as: baxdrostat (formerly CIN-107) tablet

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 0 to 23 days after dosing

  2. 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.

    Time frame: 0 to 21 days after dosing

  3. 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.

    Time frame: 0 to 21 days after dosing

  4. 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.

    Time frame: 0 to 21 days after dosing

  5. 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.

    Time frame: 0 to 21 days after dosing

  6. 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.

    Time frame: 0 to 21 days after dosing

  7. 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.

    Time frame: 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).

    Time frame: 0 to 21 days after dosing

07

Study locations

1 site
  • Medpace
    Cincinnati, Ohio 45227, United States
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan

Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. A Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.

Data sharing details ↗ · vivli.org

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2020 to primary completion in Apr 2020, 1 month.

Of 111 industry-sponsored phase 1 interventional studies under Hypertension, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 15. This study's 1 month is below that.

Counting every sponsor, half of 158 studies reached it within 9 months; a quarter within 2 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 3, 2023
First posted
Jul 27, 2023
StartActual
Mar 11, 2020
Primary completionActual
Apr 29, 2020
CompletionActual
Apr 29, 2020
Last update
Aug 14, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05963009
Lead sponsor
AstraZeneca
Responsible party
Sponsor
First posted
Jul 27, 2023
Start date
Mar 11, 2020
Primary completion
Apr 29, 2020
Completion
Apr 29, 2020
Last update
Aug 14, 2023

Study contacts

L Vrishabhendra, MD
principal investigator · Medpace, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Baxdrostat

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