The purpose of this study is to assess the safety, tolerability, pharmacokinetics and pharmacokinetics, and pharmacodynamics of HJB647 following single dose administration in Japanese healthy participants with elevated blood pressure and multiple dose administration with up titration in Japanese patients with hypertension, to support future clinical development of HJB647
Randomized, placebo-controlled, participant- and investigator-blind study consisting of two parts: * Part 1 (SAD part): Single oral dose in healthy participants. Sentinel dosing will be applied in each cohort. * Part 2 (MAD part): Multiple oral doses in patients with hypertension. Safety reviews will guide dose escalation and up-titration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
64
Novartis Investigative Site
Sumida Ku, Tokyo, Japan
RECRUITINGPart 1: Cmax
Cmax: The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)
Time frame: Part 1 on Day 1
Part 1: Tmax
Tmax: The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
Time frame: Part 1 on Day 1
Part 1: AUClast
AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)
Time frame: Part 1 on Day 1
Part 1: AUCinf
AUCinf: The AUC from time zero to infinity (mass x time x volume-1)
Time frame: Part 1 on Day 1
Part 1: T1/2
T1/2: The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Use qualifier for other half-lives
Time frame: Part 1 on Day 1
Part 2: Number of participants with AEs
Number of participants with adverse events (AEs) including abnormal vital signs, ECG, and safety laboratory parameters
Time frame: Up to 51 days
Part 1: Number of participants with AEs
Number of participants with adverse events (AEs) including abnormal vital signs, ECG, and safety laboratory parameters
Time frame: Up to 31 days
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Part 2: Cmax
Cmax: The maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1)
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: Tmax
Tmax: The time to reach maximum (peak) plasma, blood, serum, or other body fluid drug concentration after single dose administration (time)
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUClast
AUClast: The AUC from time zero to the last measurable concentration sampling time (tlast) (mass x time x volume-1)
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUCinf
AUCinf: The AUC from time zero to infinity (mass x time x volume-1)
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: AUCtau
AUCtau: The AUC calculated to the end of a dosing interval (tau) at steady-state (amount x time x volume-1)
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: T1/2
T1/2: The elimination half-life associated with the terminal slope (λz) of a semi logarithmic concentration-time curve (time). Use qualifier for other half-lives
Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21
Part 2: Office blood pressure change from baseline
Change in office blood pressure from baseline
Time frame: Baseline to Day 27 of part 2
Part 2: Heart rate change from baseline
Change in heart rate from baseline
Time frame: Baseline to Day 27 of part 2