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

ConditionsElevated Blood PressureHypertension
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNovartis Pharmaceuticals

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Male: ≥ 50.0 kg

Female: ≥ 45.0 kg

Disqualifiers

Significant illness, including infectious diseases that have not resolved within 30 days prior to baseline

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • HJB647

    Drug

    HJB647 oral capsule

  • Placebo

    Drug

    Matching oral placebo

Treatment groups

64 Participants
are divided into 10 treatment groups

10

Treatment groups

See each treatment group below.

Group A: Part 1-1: HJB647 low doseExperimental treatment 1 intervention
Group B: Part 1-2: HJB647 mid-doseExperimental treatment 1 intervention
Group C: Part 1-3: HJB647 high doseExperimental treatment 1 intervention
Group D: Part 1: PlaceboPlacebo comparator 1 intervention
Group E: Part 2-1: HJB647 multiple oral dosesExperimental treatment 1 intervention
Group F: Part 2-2: HJB647 multiple oral doses (optional cohort)Experimental treatment 1 intervention
Group G: Part 2-3: HJB647 multiple oral doses (optional cohort)Experimental treatment 1 intervention
Group H: Part 2-4: HJB647 multiple oral doses (optional cohort)Experimental treatment 1 intervention
Group I: Part 2-5: HJB647 multiple oral doses (optional cohort)Experimental treatment 1 intervention
Group J: Part 2: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Part 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
2

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
3

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
4

Part 1: AUCinf

AUCinf: The AUC from time zero to infinity (mass x time x volume-1)

Time frame
Part 1 on Day 1

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Novartis Investigative SiteRecruiting1300004, Sumida Ku, TokyoJapanJapan

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Novartis Pharmaceuticals

Lead sponsor

Source ClinicalTrials.gov
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