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Recruiting NCT07644364

HJB647 Phase 1b Study in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension

Phase I Interventional Elevated Blood Pressure Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: HJB647, Placebo.
Who it may be relevant to
Registry conditions: Elevated Blood Pressure, Hypertension. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase 1b, Randomized, Participant- and Investigator- Blinded, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HJB647 Following Single Ascending Dose and Up-titration Multiple Dose Administration in Japanese Healthy Participants With Elevated Blood Pressure and Patients With Hypertension

Overview

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

Detailed description

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.

Interventions

  • Drug HJB647
    HJB647 oral capsule
  • Drug Placebo
    Matching oral placebo

Primary outcome measures

  • Part 1: Cmax [Time frame: Part 1 on Day 1]
  • Part 1: Tmax [Time frame: Part 1 on Day 1]
  • Part 1: AUClast [Time frame: Part 1 on Day 1]
  • Part 1: AUCinf [Time frame: Part 1 on Day 1]
  • Part 1: T1/2 [Time frame: Part 1 on Day 1]
  • Part 2: Number of participants with AEs [Time frame: Up to 51 days]
Secondary outcome measures (9)
  • Part 1: Number of participants with AEs [Time frame: Up to 31 days]
  • Part 2: Cmax [Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21]
  • Part 2: Tmax [Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21]
  • Part 2: AUClast [Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21]
  • Part 2: AUCinf [Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21]
  • Part 2: AUCtau [Time frame: Part 2 Day 1, Day 7, Day 8, Day 14, Day 15 and Day 21]
  • Part 2: T1/2 [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 [Time frame: Baseline to Day 27 of part 2]
  • Part 2: Heart rate change from baseline [Time frame: Baseline to Day 27 of part 2]

Eligibility criteria

Inclusion criteria

  • Japanese healthy participants with elevated blood pressure (Part 1) and patients with mild-to-moderate hypertension (Part 2)
  • Age: 18 to 55 years (Part 1) and 18 to 60 years (Part 2)
  • Body weight:
  • Male: ≥ 50.0 kg
  • Female: ≥ 45.0 kg
  • Body Mass Index (BMI): 18.0 to 30.0 kg/m²
  • Axillary body temperature: 35.0-37.5 °C
  • Heart rate: 50-90 bpm
  • Blood pressure criteria are as follows:
  • Part 1: Healthy Participants with Elevated Blood Pressure Screening: Systolic Blood Pressure (SBP): 120 ≤ SBP ≤ 139 mmHg; Diastolic Blood Pressure (DBP): 60 ≤ DBP ≤ 94 mmHg Baseline (Day -1): SBP: 120 ≤ SBP ≤ 179 mmHg; DBP: 60 ≤ DBP ≤ 109 mmHg
  • Part 2: Patients with Hypertension Screening and Baseline (Day -1): SBP: 140 ≤ SBP ≤ 179 mmHg; DBP: 60 ≤ DBP ≤ 109 mmHg

Exclusion criteria

  • Significant illness, including infectious diseases that have not resolved within 30 days prior to baseline
  • History or current diagnosis of ECG or cardiac abnormalities indicating significant risk of safety for participants such as:
  • Concomitant clinically significant cardiac arrhythmias, e.g., sustained ventricular tachycardia, and clinically significant second- or third-degree AV block without a pacemaker.
  • History of familial long QT syndrome or known family history of Torsades de Pointes
  • Resting QT interval corrected by Fridericia's formula (QTcF) ≥ 450 msec (male) or ≥ 460 msec (female) at screening
  • At screening, hypokalemia or hypomagnesemia defined as potassium or magnesium values below the LLN on repeat measurement, or laboratory abnormalities indicating hypothyroidism, as determined at the discretion of the investigator
  • HbA1c ≥ 7.0% or LDL cholesterol ≥ 180 mg/dL or triglycerides ≥ 250 mg/dL
  • Use of any prescription drugs or herbal supplements within 4 weeks prior to initial dosing, and/or OTC medication or dietary supplements (vitamins included) within 2 weeks prior to initial dosing
  • Women of childbearing potential

Other protocol-defined inclusion/exclusion criteria may apply

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Japan · 1 center
  • Novartis Investigative Site — Sumida Ku

Identifiers

NCT: NCT07644364 · CHJB647A11101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗