Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of XXB750 in Healthy Participants
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
XXB750 in Healthy Participants
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This study was a randomized, participant and investigator-blinded, placebo-controlled, single-ascending dose study, consisting of 9 sequential dose cohorts (1 mg, 3 mg, 10 mg, 30 mg, 60 mg, 120 mg, 24...
Detailed Description
Eligible healthy participants with normal blood pressure (SBP: 110-139 mmHg; DBP: 70-89 mmHg) were randomized into dose cohorts 1 - 240 mg. Eligible healthy participants with elevated blood pressure (...
Eligibility Criteria
Inclusion
- Healthy male and female participants age 18 to 50 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2
- For ethnic Japanese cohort: participants must be defined as being of first, second or third generation ethnic origin, with each set of parents qualifying as Japanese under the prior generation.
Exclusion
- Any surgical or medical condition which significantly altered the distribution, metabolism, or excretion of drugs, or which jeopardized the participant's participation in the study.
- Known history or current clinically significant arrhythmias.
- Women of child-bearing potential were excluded from this study.
Key Trial Info
Start Date :
July 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2023
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT06558097
Start Date
July 29 2020
End Date
March 31 2023
Last Update
August 16 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Novartis Investigative Site
Cypress, California, United States, 90630