HypertensionPhase 1NCT05470725

Study to Evaluate the Pharmacokinetics of CIN-107 in Subjects With Varying Degrees of Renal Function

A Phase 1 study testing CIN-107 in people with Hypertension, run by AstraZeneca at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

This is a Phase 1, open-label, parallel-group study in subjects with varying degrees of renal function to assess the safety, tolerability, and Pharmacokinetics of a single 10 mg oral dose of CIN-107. Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Hypertension
What is being tested?: CIN-107
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 33 participants
Where: 2 sitesUnited States
Study dates: 12 Jan 2021to 30 Apr 2021
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Subjects in stable health based on medical and psychiatric history, physical examination, ECG, vital signs (seated and orthostatic), and routine laboratory tests (chemistry, hematology, coagulation, and urinalysis); Note: Underlying medical conditions consistent with the population under study are acceptable if the subject's condition is considered stable by the Investigator. For renally impaired subjects, their renal status must be stable for a minimum of 3 months prior to screening.
Does not use nicotine-containing products at all or smokes <10 cigarettes/day (approximately <half pack/day);
Body mass index (BMI) between 18 and 40 kg/m2, inclusive;

Who cannot join

Active participation in another experimental therapy study of a small molecule other than CIN-107 within 30 days prior to Day 1 or 5 half-lives, whichever is longer; or received a large molecule within 90 days prior to Day 1 or 5 half-lives, whichever is longer;
History of prior organ transplant or planned transplant within 6 months of screening;
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, chronic persistent 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 for males or >470 msec for females) based on the average of triplicate ECGs;
Evidence of any of the following clinical measurements:

Show all 27Show fewer

Seated systolic BP >160 mmHg and/or diastolic BP >100 mmHg, or systolic BP <90 mmHg and/or diastolic BP <50 mmHg;
Resting heart rate >100 beats per minute (bpm) or <50 bpm;
Oral temperature >37.6°C (>99.68°F);
Respiration rate 20 breaths/minute;
Postural tachycardia (ie, an increase in heart rate >30 bpm upon standing from a seated position);
Orthostatic hypotension (ie, a fall in systolic BP ≥20 mmHg or diastolic BP ≥10 mmHg upon standing from a seated position);
Clinically significant abnormal serum potassium >upper limit of normal of the reference range (ULN);
Clinically significant abnormal serum sodium 1.5 x ULN;
Aspartate aminotransferase or alanine aminotransferase values >1.5 x ULN
Total bilirubin >2 x ULN, unless due to Gilbert's syndrome;
Positive test for HIV antibody, hepatitis C virus (HCV) RNA, hepatitis B surface antigen (HBsAg), or SARS-CoV-2 RNA; or
History of porphyria, myopathy, or active liver disease;
Inadequate venous access;
Current treatment with weight loss medication or prior weight loss surgery (eg, gastric bypass surgery);
Use of a strong inducer of CYP3A4 within 28 days prior to the dose of study drug;
Corticosteroid use (systemic or extensive topical use) within 3 months prior to study drug dosing;
Positive drug or alcohol test result without medical explanation or a history of alcoholism or drug abuse within 2 years prior to study drug dosing as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition;
Typical consumption of ≥14 alcoholic drinks weekly;
Surgical procedures within 4 weeks prior to study drug dosing or planned elective surgery during the study period;
Any clinically significant illness within 4 weeks prior to study drug dosing, unless deemed not clinically significant by the Investigator;
Pregnant, breastfeeding, or planning to become pregnant during the study;

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Orlando Clinical Research Center
Orlando, Florida, 32809
Genesis Clinical Trials
Tampa, Florida, 33603

Other trials in United States

About this study

Official title: A Phase 1, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of CIN-107 in Subjects With Varying Degrees of Renal Function

This is a Phase 1, open-label, parallel-group study in subjects with varying degrees of renal function to assess the safety, tolerability, and Pharmacokinetics of a single 10 mg oral dose of CIN-107.

Conditions: Hypertension
Being tested: CIN-107
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CIN-107Drug
Also called baxdrostat
A single 10 mg CIN-107 oral dose (2 X 5 mg tablets).

Study groups in NCT05470725
Study group	Role	What they receive
Control (normal renal function or mild renal impairment)	Experimental	Estimated glomerular filtration rate (eGFR) ≥60 mL/min Receives: Drug: CIN-107
Moderate to severe renal impairment	Experimental	eGFR 15 to 59 mL/min Receives: Drug: CIN-107
Kidney failure	Experimental	eGFR <15 mL/min, including: * Subjects not on dialysis; and * Subjects on dialysis, with study drug administration on a non-dialysis day Receives: Drug: CIN-107

What is being measured

The primary outcome is the main question the study is designed to answer.

Maximum plasma concentration (Cmax)
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Measured: up to Day 8
Time to maximum plasma concentration (Tmax)
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Measured: up to Day 8
Area under the curve from time 0 to the time of last quantifiable plasma concentration (AUC[0-last])
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Measured: up to Day 8
Area under the curve from time 0 to infinity (AUC[0-inf])
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Measured: up to Day 8
Percent of AUC extrapolated
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Measured: up to Day 8
Terminal phase elimination half-life
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Measured: up to Day 8
Apparent plasma clearance (CL/F)
This PK parameter will be determined for CIN-107 using plasma concentration data.
Measured: up to Day 8
Apparent volume of distribution
This PK parameter will be determined for CIN-107 using plasma concentration data.
Measured: up to Day 8
The cumulative amount of CIN-107 and CIN-107-M excreted in the urine (Ae)
This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)
Measured: up to Day 8
Renal clearance (CLR) of CIN-107 and CIN-107-M of CIN-107 and CIN-107-M
Calculated as Ae/AUC. This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)
Measured: up to Day 8
The fraction of the dose excreted renally
This PK parameter will be calculated using the urine concentrations of CIN-107
Measured: up to Day 8
Number of patients experiencing adverse events (AEs)
Measured: up to Day 11
Number of patients experiencing adverse drug reactions
Measured: up to Day 11
Number of patients experiencing serious adverse events (SAEs)
Measured: up to Day 11

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jan 202130 Apr 2021

First posted22 Jul 2022
Study start12 Jan 2021
Primary completion30 Apr 2021
Study completion30 Apr 2021

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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 33 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05470725
Sponsor's protocol ID: CIN-107-113
Status last verified: Aug 2023
First submitted: 20 Jul 2022
Last updated: 14 Aug 2023
Results posted: No
Data monitoring committee: Yes
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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

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, Open-Label, Single-Dose, Parallel-Group Study to Evaluate the Pharmacokinetics of CIN-107 in Subjects With Varying Degrees of Renal Function
ClinicalTrials.gov ID: NCT05470725
Acronym / sponsor ID: CIN-107-113
Conditions: Hypertension
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 33 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 12 Jan 2021 (actual)
Primary completion: 30 Apr 2021 (actual)
Study completion: 30 Apr 2021 (actual)
First posted: 22 Jul 2022 (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 is a Phase 1, open-label, parallel-group study in subjects with varying degrees of renal function to assess the safety, tolerability, and Pharmacokinetics of a single 10 mg oral dose of CIN-107.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control (normal renal function or mild renal impairment)	Experimental	Drug: CIN-107Estimated glomerular filtration rate (eGFR) ≥60 mL/min
Moderate to severe renal impairment	Experimental	Drug: CIN-107eGFR 15 to 59 mL/min
Kidney failure	Experimental	Drug: CIN-107eGFR <15 mL/min, including: * Subjects not on dialysis; and * Subjects on dialysis, with study drug administration on a non-dialysis day

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Subjects in stable health based on medical and psychiatric history, physical examination, ECG, vital signs (seated and orthostatic), and routine laboratory tests (chemistry, hematology, coagulation, and urinalysis); Note: Underlying medical conditions consistent with the population under study are acceptable if the subject's condition is considered stable by the Investigator. For renally impaired subjects, their renal status must be stable for a minimum of 3 months prior to screening.
Does not use nicotine-containing products at all or smokes <10 cigarettes/day (approximately <half pack/day);
Body mass index (BMI) between 18 and 40 kg/m2, inclusive;

Key exclusion criteria (27 listed)

Active participation in another experimental therapy study of a small molecule other than CIN-107 within 30 days prior to Day 1 or 5 half-lives, whichever is longer; or received a large molecule within 90 days prior to Day 1 or 5 half-lives, whichever is longer;
History of prior organ transplant or planned transplant within 6 months of screening;
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, chronic persistent 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 for males or >470 msec for females) based on the average of triplicate ECGs;

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
CIN-107Also: baxdrostatA single 10 mg CIN-107 oral dose (2 X 5 mg tablets).	Drug	Control (normal renal function or mild renal impairment), Kidney failure, Moderate to severe renal impairment

Primary outcome

Maximum plasma concentration (Cmax)
Time frame: up to Day 8
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Time to maximum plasma concentration (Tmax)
Time frame: up to Day 8
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Area under the curve from time 0 to the time of last quantifiable plasma concentration (AUC[0-last])
Time frame: up to Day 8
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Area under the curve from time 0 to infinity (AUC[0-inf])
Time frame: up to Day 8
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Percent of AUC extrapolated
Time frame: up to Day 8
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Terminal phase elimination half-life
Time frame: up to Day 8
This PK parameter will be determined for CIN-107, its primary metabolite (CIN-107-M), and any other measured metabolites using plasma concentration data, as the data permit.
Apparent plasma clearance (CL/F)
Time frame: up to Day 8
This PK parameter will be determined for CIN-107 using plasma concentration data.
Apparent volume of distribution
Time frame: up to Day 8
This PK parameter will be determined for CIN-107 using plasma concentration data.
The cumulative amount of CIN-107 and CIN-107-M excreted in the urine (Ae)
Time frame: up to Day 8
This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)
Renal clearance (CLR) of CIN-107 and CIN-107-M of CIN-107 and CIN-107-M
Time frame: up to Day 8
Calculated as Ae/AUC. This PK parameter will be calculated using the urine concentrations of CIN-107 and its primary metabolite (CIN-107-M)
The fraction of the dose excreted renally
Time frame: up to Day 8
This PK parameter will be calculated using the urine concentrations of CIN-107
Number of patients experiencing adverse events (AEs)
Time frame: up to Day 11
Number of patients experiencing adverse drug reactions
Time frame: up to Day 11
Number of patients experiencing serious adverse events (SAEs)
Time frame: up to Day 11

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.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
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An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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 CIN-107 in people with Hypertension, run by AstraZeneca 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 3 inclusion and 27 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 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?

Maximum plasma concentration (Cmax) (time frame: up to Day 8). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05470725.

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.