Study identifier:D6970C00004
ClinicalTrials.gov identifier:NCT06194032
EudraCT identifier:N/A
CTIS identifier:N/A
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
Healthy Participants
Phase 1
Yes
Baxdrostat, Placebo, Moxifloxacin
All
28
Interventional
18 Years - 55 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Crossover Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 May 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Treatment Sequence ABCD 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. | Drug: Baxdrostat Participants will receive baxdrostat as two separate doses. Drug: Placebo Participants will receive baxdrostat matching placebo. Drug: Moxifloxacin Participants will receive a single dose moxifloxacin |
Experimental: Treatment Sequence BDAC 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. | Drug: Baxdrostat Participants will receive baxdrostat as two separate doses. Drug: Placebo Participants will receive baxdrostat matching placebo. Drug: Moxifloxacin Participants will receive a single dose moxifloxacin |
Experimental: Treatment Sequence CADB 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. | Drug: Baxdrostat Participants will receive baxdrostat as two separate doses. Drug: Placebo Participants will receive baxdrostat matching placebo. Drug: Moxifloxacin Participants will receive a single dose moxifloxacin |
Experimental: Treatment Sequence DCBA 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. | Drug: Baxdrostat Participants will receive baxdrostat as two separate doses. Drug: Placebo Participants will receive baxdrostat matching placebo. Drug: Moxifloxacin Participants will receive a single dose moxifloxacin |