Cardiac Repolarization, Healthy Volunteers
Conditions
Brief summary
This is a Phase 1, multicenter, randomized, double-blind, double-dummy, single dose, placebo- and positive-controlled, 4-sequence, 4-treatment, 4-period crossover study.
Interventions
DRUGBalinatunfib
Pharmaceutical form: Tablet Route of administration: Oral
DRUGMoxifloxacin
Pharmaceutical form: Tablet Route of administration: Oral
DRUGPlacebo
Pharmaceutical form: Tablet Route of administration: Oral
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Williams design
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Age: Healthy males and/or females aged 18 to 55 (inclusive) at consent signing. * Certified healthy based on history, physical exam, vitals, ECG, and labs with no abnormalities. * Weight: 50-100 kg (male), 40-90 kg (female); BMI 18-30 kg/m² inclusive. * Sex-based eligibility: All males must use effective contraception or remain abstinent and avoid sperm donation for 3 months post-dose. Females must use highly effective contraception, not be pregnant or breastfeeding, and test negative for pregnancy before treatment.
Exclusion criteria
* History of significant systemic diseases (hematologic, renal, endocrine, pulmonary, GI, cardiac, hepatic, psychiatric, neurologic, infectious, allergic; except mild seasonal allergies). * Clinically significant ECG abnormalities. * Frequent headaches or migraines, and recurrent nausea or vomiting (over twice monthly). * Blood donation within 2 months. * Symptomatic or significant postural hypotension. * Drug hypersensitivity or significant allergies, including to study drugs. * History of drug/alcohol abuse. * Tobacco use within 3 months prior to Day 1. * History of Hepatitis B/C, TB, or invasive opportunistic infections. * Malignancy within 5 years (except treated non-metastatic skin cancer). * Adverse reaction to balinatunfib, moxifloxacin, or quinolones. * Any medication (except hormonal contraception/HRT) within 14 days or 5× half-life. * Biologics within 4 months prior. * Vaccines: non-live within 4 weeks, live within 3 months before or during study. * Current or recent participation in another interventional study within 30 days. * Positive for HBsAg, anti-HBc, anti-HCV, anti-HIV1/2. * Positive urine drug screen. * Positive alcohol breath test. * Positive urine cotinine test. * History of long QT syndrome. * Risk factors for TdP. * Moxifloxacin contraindications. * Low potassium (\<3.5 mmol/L). * Low magnesium (\<0.7 mmol/L). The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the QT interval corrected using the Fridericia formula (QTcF) centrally assessed using a semi-automatic reading | Baseline to day 2 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in heart rate (HR) | Day 1 to Day 2 |
| Change from baseline in QT interval | Baseline to day 2 of each period |
| Change from baseline in QT interval corrected using the Bazett formula (QTcB) | Baseline to day 2 of each period |
| Change from baseline in population specific QT correction (QTcN) interval | Baseline to day 2 of each period |
| Change from baseline in QRS interval | Baseline to day 2 of each period |
| Change from baseline in PR interval | Baseline to day 2 of each period |
| Safety for electrocardiogram (ECG) parameters | Baseline to day 83 |
| Maximum plasma concentration (Cmax) for balinatunfib | Baseline to day 6 of each period |
| Time to reach the maximum concentration (tmax) for balinatunfib | Baseline to day 6 of each period |
| Area under the curve (AUC) for balinatunfib | Baseline to day 6 of each period |
| Maximum plasma concentration (Cmax) for balinatunfib metabolite M8 | Baseline to day 6 of each period |
| Time to reach the maximum concentration (tmax) for balinatunfib metabolite M8 | Baseline to day 6 of each period |
| Area under the curve (AUC) for balinatunfib metabolite M8 | Baseline to day 6 of each period |
| Number of participants experiencing treatment-emergent adverse events (TEAEs) including adverse events of special interest (AESIs) and serious adverse events (SAEs) | Baseline to Day 83 |
| Number of participants with clinical laboratory and vital signs abnormalities (potentially clinically significant abnormality) | Baseline to Day 83 |
Countries
United States
Outcome results
None listed