Healthy ParticipantsPhase 1NCT06194032
A Study to Investigate the Effect on QTcF of Baxdrostat Compared With Placebo, Using Moxifloxacin as a Positive Control, in Healthy Participants
A Phase 1 study testing Baxdrostat and Moxifloxacin in people with Healthy Participants, run by AstraZeneca at 1 site in Germany.
Trial summary
This study will assess the effect of single oral doses of baxdrostat on the ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) interval corrected for HR using Fridericia's formula (QTcF) compared to placebo using a concentration-QTcF analysis, and with moxifloxacin as positive… Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- Baxdrostat and Moxifloxacin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- 29 Feb 2024to 13 May 2024
- 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
- Females must have a negative pregnancy test.
- Have a Basal Metabolic index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg.
Who cannot join
- History of any clinically significant disease or disorder.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- History of additional risk factors for Torsade de Pointes.
- History of neoplastic disease.
- Family history of sudden cardiac death.
- Any skin condition likely to interfere with ECG electrode placement or adhesion.
Show all 15Show fewer
- Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of drug.
- Any clinically significant abnormalities at screening and first admission in rhythm, conduction, or morphology of the 12-lead resting ECG and any clinically important abnormalities in the 12-lead ECG as considered by the investigator.
- Participant has clinical signs and symptoms consistent with COVID-19.
- Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.
- Positive screen for drugs of abuse, alcohol or cotinine at screening or on each admission to the Clinical Unit.
- Participants who have previously received Baxdrostat.
- Participants with any special dietary restrictions such as participants who are lactose intolerant or are vegetarians/vegans.
- Participants who cannot communicate reliably with the investigator and/or are not able to read, speak, and understand the local language.
- Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-centre, Randomised, Double-blind, Placebo-controlled, Four-Way Crossover Phase I Thorough QTc Study to Investigate the Effect on QTcF of Single Doses of Baxdrostat Compared With Placebo, Using Open-label Moxifloxacin as a Positive Control, in Healthy Participants
This study will assess the effect of single oral doses of baxdrostat on the ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) interval corrected for HR using Fridericia's formula (QTcF) compared to placebo using a concentration-QTcF analysis, and with moxifloxacin as positive control, in healthy participants.
Read the detailed description
This is a randomised, placebo-controlled, double-blind, 4-way crossover TQT study to assess the effect of single oral doses of baxdrostat on the QTcF compared to placebo using a concentration-QTcF analysis, and with open-label moxifloxacin as positive control, in 28 healthy participants, performed at a single clinical unit.
The study will comprise of:
- a screening period of maximum 28 days,
- four treatment periods during which participants will be resident at the Clinical Unit from Treatment Period Day -1 until at least 48 hours after dosing (Treatment Period Day 3).
- a final Follow-up Visit within 7 to 10 days following discharge after Visit 5
Participants will each receive a single dose of all treatments in a cross-over design over 4 treatment periods. Participants will be randomised to 1 of 4 treatment sequences with equal allocation regarded as a Williams design of order 4.
Treatment Periods will be separated by a washout period of at least 7 days but no more than 9 days.
- Conditions
- Healthy Participants
- Being tested
- Baxdrostat, Placebo, Moxifloxacin
- Keywords
- Aldosterone synthase inhibitor, QT/QTc interval, Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BaxdrostatDrug
Participants will receive baxdrostat as two separate doses.
PlaceboDrug
Participants will receive baxdrostat matching placebo.
MoxifloxacinDrug
Participants will receive a single dose moxifloxacin
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence ABCD | Experimental | Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (ABCD) in a crossover design with a washout period of at least 7 days between each study dose administration. Receives: Drug: Baxdrostat; Drug: Placebo; Drug: Moxifloxacin |
| Treatment Sequence BDAC | Experimental | Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (BDAC) in a crossover design with a washout period of at least 7 days between each study dose administration. Receives: Drug: Baxdrostat; Drug: Placebo; Drug: Moxifloxacin |
| Treatment Sequence CADB | Experimental | Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (CADB) in a crossover design with a washout period of at least 7 days between each study dose administration. Receives: Drug: Baxdrostat; Drug: Placebo; Drug: Moxifloxacin |
| Treatment Sequence DCBA | Experimental | Dummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (DCBA) in a crossover design with a washout period of at least 7 days between each study dose administration. Receives: Drug: Baxdrostat; Drug: Placebo; Drug: Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Placebo corrected change from baseline in QTcF (ΔΔQTcF)
The effect of single doses of baxdrostat on QTcF compared to placebo using a concentration-QTcF analysis will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Secondary outcomes (29)
Heart Rate (HR)
The effect of baxdrostat on HR will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
RR interval
The effect of baxdrostat on RR interval will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
PR interval
The effect of baxdrostat on PR interval will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
QRS interval
The effect of baxdrostat on QRS interval will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in Heart rate (ΔHR)
The effect of baxdrostat on HR will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
QT interval
The effect of baxdrostat on QT interval will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in RR interval (ΔRR)
The effect of baxdrostat on ΔRR interval will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in PR interval (ΔPR)
The effect of baxdrostat on ΔPR interval will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in QRS interval (ΔQRS)
The effect of baxdrostat on ΔQRS interval will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in QTcF (ΔQTcF)
The effect of baxdrostat on ΔQTcF will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in QT interval (ΔQT)
The effect of baxdrostat on ΔQT interval will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Number of participants with significant change in QTcF
The presence of categorical outliers for QTcF after baxdrostat administration will be assessed.
Measured: Day 1 to Day 3
Number of participants with significant change in PR interval
The presence of categorical outliers for PR interval after baxdrostat administration will be assessed.
Measured: Day 1 to Day 3
Number of participants with significant change in QRS interval
The presence of categorical outliers for QRS interval after baxdrostat administration will be assessed.
Measured: Day 1 to Day 3
Number of participants with significant change in RR interval
The presence of categorical outliers for RR interval after baxdrostat administration will be assessed.
Measured: Day 1 to Day 3
Number of participants with significant change in QT interval
The presence of categorical outliers for QT interval after baxdrostat administration will be assessed.
Measured: Day 1 to Day 3
Number of participants with significant change in HR
The presence of categorical outliers for HR after baxdrostat administration will be assessed.
Measured: Day 1 to Day 3
Placebo corrected change from baseline in HR (ΔΔHR)
The effect of baxdrostat on ΔΔHR will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Placebo corrected change from baseline in RR interval (ΔΔRR)
The effect of baxdrostat on ΔΔRR interval will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Placebo corrected change from baseline in PR interval (ΔΔPR)
The effect of baxdrostat on ΔΔPR interval will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Placebo corrected change from baseline in QRS (ΔΔQRS)
The effect of baxdrostat on ΔΔQRS interval will be assessed.
Measured: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
AUClast of Baxdrostat
The PK of baxdrostat will be assessed.
Measured: Day 1 to Day 3
AUCinf of Baxdrostat
The PK of baxdrostat will be assessed.
Measured: Day 1 to Day 3
Maximum observed plasma peak concentration (Cmax) of baxdrostat
The PK of baxdrostat will be assessed.
Measured: Day 1 to Day 3
Time to reach peak or maximum observed concentration (Tmax) of baxdrostat
The PK of baxdrostat will be assessed.
Measured: Day 1 to Day 3
Number of participants with Adverse Events (AEs)
The safety and tolerability of baxdrostat will be assessed.
Measured: Day 1 to last day of follow-up (approximately 7 to 10 days after the last dose)
Number of participants with Adverse events of special interest
The safety and tolerability of baxdrostat will be assessed. For this clinical study, AESIs include the following: hyperkalaemia, hyponatraemia, and hypotension events that require intervention.
Measured: Day 1 to last day of follow-up (approximately 7 to 10 days after the last dose)
Number of treatment-emergent changes in T-wave morphology
Morphological changes in the T-wave after baxdrostat administration will be assessed.
Measured: Day 1 to Day 3
Number of treatment-emergent changes in U-waves presence and morphology
Morphological changes in the U wave after baxdrostat administration will be assessed.
Measured: Day 1 to Day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start29 Feb 2024
- Primary completion13 May 2024
- Study completion13 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194032
- Sponsor's protocol ID
- D6970C00004
- Other IDs
- 2023-506108-23-00, 2023
- Status last verified
- Apr 2025
- First submitted
- 21 Dec 2023
- Last updated
- 25 Apr 2025
- 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 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-centre, Randomised, Double-blind, Placebo-controlled, Four-Way Crossover Phase I Thorough QTc Study to Investigate the Effect on QTcF of Single Doses of Baxdrostat Compared With Placebo, Using Open-label Moxifloxacin as a Positive Control, in Healthy Participants
- ClinicalTrials.gov ID
- NCT06194032
- Acronym / sponsor ID
- D6970C00004
- Conditions
- Healthy Participants
- Keywords
- Aldosterone synthase inhibitor, QT/QTc interval, Moxifloxacin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 29 Feb 2024 (actual)
- Primary completion
- 13 May 2024 (actual)
- Study completion
- 13 May 2024 (actual)
- First posted
- 8 Jan 2024 (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 study will assess the effect of single oral doses of baxdrostat on the ECG interval measured from the onset of the QRS complex to the end of the T wave (QT) interval corrected for HR using Fridericia's formula (QTcF) compared to placebo using a concentration-QTcF analysis, and with moxifloxacin as positive control, in healthy participants.
Detailed description
This is a randomised, placebo-controlled, double-blind, 4-way crossover TQT study to assess the effect of single oral doses of baxdrostat on the QTcF compared to placebo using a concentration-QTcF analysis, and with open-label moxifloxacin as positive control, in 28 healthy participants, performed at a single clinical unit.
The study will comprise of:
- a screening period of maximum 28 days,
- four treatment periods during which participants will be resident at the Clinical Unit from Treatment Period Day -1 until at least 48 hours after dosing (Treatment Period Day 3).
- a final Follow-up Visit within 7 to 10 days following discharge after Visit 5
Participants will each receive a single dose of all treatments in a cross-over design over 4 treatment periods. Participants will be randomised to 1 of 4 treatment sequences with equal allocation regarded as a Williams design of order 4.
Treatment Periods will be separated by a washout period of at least 7 days but no more than 9 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence ABCD | Experimental | Drug: Baxdrostat, Drug: Placebo, Drug: MoxifloxacinDummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (ABCD) in a crossover design with a washout period of at least 7 days between each study dose administration. |
| Treatment Sequence BDAC | Experimental | Drug: Baxdrostat, Drug: Placebo, Drug: MoxifloxacinDummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (BDAC) in a crossover design with a washout period of at least 7 days between each study dose administration. |
| Treatment Sequence CADB | Experimental | Drug: Baxdrostat, Drug: Placebo, Drug: MoxifloxacinDummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (CADB) in a crossover design with a washout period of at least 7 days between each study dose administration. |
| Treatment Sequence DCBA | Experimental | Drug: Baxdrostat, Drug: Placebo, Drug: MoxifloxacinDummy sequence according to CSP: Participants will receive a single dose of all 4 treatments (DCBA) in a crossover design with a washout period of at least 7 days between each study dose administration. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Females must have a negative pregnancy test.
- Have a Basal Metabolic index (BMI) between 19 and 30 kg/m2 inclusive and weigh at least 50 kg.
Key exclusion criteria (15 listed)
- History of any clinically significant disease or disorder.
- History or presence of gastrointestinal, hepatic, or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
- History of additional risk factors for Torsade de Pointes.
- History of neoplastic disease.
- Family history of sudden cardiac death.
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 |
|---|---|---|
| BaxdrostatParticipants will receive baxdrostat as two separate doses. | Drug | Treatment Sequence ABCD, Treatment Sequence BDAC, Treatment Sequence CADB, Treatment Sequence DCBA |
| PlaceboParticipants will receive baxdrostat matching placebo. | Drug | Treatment Sequence ABCD, Treatment Sequence BDAC, Treatment Sequence CADB, Treatment Sequence DCBA |
| MoxifloxacinParticipants will receive a single dose moxifloxacin | Drug | Treatment Sequence ABCD, Treatment Sequence BDAC, Treatment Sequence CADB, Treatment Sequence DCBA |
Primary outcome
Placebo corrected change from baseline in QTcF (ΔΔQTcF)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
The effect of single doses of baxdrostat on QTcF compared to placebo using a concentration-QTcF analysis will be assessed.
29 secondary outcomes
Heart Rate (HR)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
RR interval
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
PR interval
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
QRS interval
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in Heart rate (ΔHR)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
QT interval
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in RR interval (ΔRR)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in PR interval (ΔPR)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in QRS interval (ΔQRS)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in QTcF (ΔQTcF)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Change from baseline in QT interval (ΔQT)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Number of participants with significant change in QTcF
Time frame: Day 1 to Day 3
Number of participants with significant change in PR interval
Time frame: Day 1 to Day 3
Number of participants with significant change in QRS interval
Time frame: Day 1 to Day 3
Number of participants with significant change in RR interval
Time frame: Day 1 to Day 3
Number of participants with significant change in QT interval
Time frame: Day 1 to Day 3
Number of participants with significant change in HR
Time frame: Day 1 to Day 3
Placebo corrected change from baseline in HR (ΔΔHR)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Placebo corrected change from baseline in RR interval (ΔΔRR)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Placebo corrected change from baseline in PR interval (ΔΔPR)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
Placebo corrected change from baseline in QRS (ΔΔQRS)
Time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose
AUClast of Baxdrostat
Time frame: Day 1 to Day 3
AUCinf of Baxdrostat
Time frame: Day 1 to Day 3
Maximum observed plasma peak concentration (Cmax) of baxdrostat
Time frame: Day 1 to Day 3
Time to reach peak or maximum observed concentration (Tmax) of baxdrostat
Time frame: Day 1 to Day 3
Number of participants with Adverse Events (AEs)
Time frame: Day 1 to last day of follow-up (approximately 7 to 10 days after the last dose)
Number of participants with Adverse events of special interest
Time frame: Day 1 to last day of follow-up (approximately 7 to 10 days after the last dose)
Number of treatment-emergent changes in T-wave morphology
Time frame: Day 1 to Day 3
Number of treatment-emergent changes in U-waves presence and morphology
Time frame: Day 1 to Day 3
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 25 Apr 2025.
- D6970C00004\_Redacted\_CSR SynopsisLink provided by the sponsor.
- Results posted on AZCT.comLink 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 Healthy Participants
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
RecruitingPhase 1
A Study to Evaluate the Metabolism, the Routes and Extent of Elimination, and Drug Levels of [14C]Navlimetostat (BMS-986504) in Healthy Female Participants
Healthy Female Participants
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
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.
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 and Moxifloxacin in people with Healthy Participants, run by AstraZeneca at 1 site in Germany.
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 2 inclusion and 15 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 25 Apr 2025. 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 Germany. 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?
Placebo corrected change from baseline in QTcF (ΔΔQTcF) (time frame: Visit 2,3, 4 and 5:- Day 1: Pre-dose, 0.5, 1, 1.5, 2,3,4,5,6, 8 and 12 hour (h); Day 2: 24 and 36 h post-dose; Day 3: 48 h post dose). 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 25 Apr 2025.