Multiple-Ascending Dose in Japanese Patients Bridging Study

NCT05065359 | Completed Phase 1 FDA Drug

• 1 other identifier: RVT-1201-1005
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy Japanese and Caucasian subjects.

Conditions

Healthy

Keywords

Pulmonary Arterial Hypertension; PAH

Outcome Measures

Primary Outcomes (1)

• Safety of rodatristat ethyl by incidence of adverse events

  Assessments of adverse events

  21 days

Secondary Outcomes (12)

• Single dose AUC(0-∞)

  21 days

• Single dose AUC(0-t)

  21 days

• Single dose Cmax

  21 days

• Single dose tmax

  21 days

• Single dose t½

  21 days

Study Arms (8)

Rodatristat Ethyl 300 mg BID - Japanese subjects

EXPERIMENTAL

Drug: Rodatristat Ethyl 300 mg BID

Placebo match for Rodatristat Ethyl 300 mg BID - Japanese subjects

PLACEBO COMPARATOR

Drug: Placebo

Rodatristat Ethyl 300 mg BID - Caucasian subjects

EXPERIMENTAL

Drug: Rodatristat Ethyl 300 mg BID

Placebo match for Rodatristat Ethyl 300 mg BID - Caucasian subjects

PLACEBO COMPARATOR

Drug: Placebo

Rodatristat Ethyl 600 mg BID - Japanese subjects

EXPERIMENTAL

Drug: Rodatristat Ethyl 600 mg BID

Placebo match for Rodatristat Ethyl 600 mg BID - Japanese subjects

PLACEBO COMPARATOR

Drug: Placebo

Rodatristat Ethyl 600 mg BID - Caucasian subjects

EXPERIMENTAL

Drug: Rodatristat Ethyl 600 mg BID

Placebo match for Rodatristat Ethyl 600 mg BID - Caucasian subjects

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Rodatristat Ethyl 300 mg BID DRUG

Tablets, oral, 300 mg, BID 14 days

Rodatristat Ethyl 300 mg BID - Caucasian subjects; Rodatristat Ethyl 300 mg BID - Japanese subjects

Rodatristat Ethyl 600 mg BID DRUG

Tablets, oral, 600 mg, BID 14 days

Rodatristat Ethyl 600 mg BID - Caucasian subjects; Rodatristat Ethyl 600 mg BID - Japanese subjects

Placebo DRUG

Tablets, oral, 0 mg, BID for 14 days

Placebo match for Rodatristat Ethyl 300 mg BID - Caucasian subjects; Placebo match for Rodatristat Ethyl 300 mg BID - Japanese subjects; Placebo match for Rodatristat Ethyl 600 mg BID - Caucasian subjects; Placebo match for Rodatristat Ethyl 600 mg BID - Japanese subjects

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males or females aged 18 to 55 years, inclusive
• A male subject is eligible to participate if he does not have a female partner who is pregnant or who intends to become pregnant during the study. Male subjects must agree to use contraception starting at Screening, during the treatment period, and for at least 100 days after the last dose of Investigational Product (IP), and refrain from donating sperm during this period.
• Female subjects of childbearing potential must agree to use contraception starting at Screening, during the treatment period, and for at least 30 days after the last dose of IP.
• Body mass index (BMI) ≥ 18 kg/m2 and ≤ 32 kg/m2 at Screening
• Japanese subjects must have been born in Japan and not have lived outside of Japan \> 10 years at the time of Screening, have both parents and grandparents of ethnic Japanese origin, and have not significantly modified their diets since leaving Japan.
• Caucasian subjects must be of European or Latin American descent (i.e., White).
• Capable of giving signed informed consent, able to understand and comply with protocol requirements, instructions, and protocol related restrictions, and likely to complete the study as planned.

You may not qualify if:

• Any known pre-existing medical or psychiatric condition that could interfere with the subject's ability to provide informed consent or participate in study conduct, or that may confound study findings including, but not limited to a history of clinically significant gastrointestinal, hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, or cardiovascular disease
• a. History of Gilbert's Syndrome
• b. History of depression
• c. History of any allergy that, in the opinion of the Investigator, contraindicates participation in the trial
• Any positive finding on the Columbia-Suicide Severity Rating Scale (C-SSRS).
• Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding volume drawn at Screening) of 50 mL to 499 mL of blood within 30 days or more than 499 mL within 56 days prior to Day 1
• Participation in an investigational drug, vaccine, or device study within 30 days before IP administration or 90 days for a biologic study
• Evidence of previous myocardial infarction
• a. Any conduction abnormality (including but not specific to atrioventricular block \[2nd degree or higher\], Wolff Parkinson White syndrome \[unless curative ablation treatment\]).
• b. Sinus pauses \> 3 seconds.
• c. Any significant arrhythmia which, in the opinion of the Investigator and Medical Monitor, will interfere with the safety for the individual subject.
• d. Non-sustained or sustained ventricular tachycardia (≥ 3 consecutive ventricular ectopic beats).
• Abnormal blood pressure, either low (defined as \< 90 mmHg systolic and/or \< 50 mmHg diastolic) or high (defined as \> 140 mmHg systolic and/or \> 90 mmHg diastolic)
• Clinically significant abnormalities in laboratory test results (including hepatic and renal panels, complete blood count, coagulation, chemistry panel, and urinalysis)
• a. Positive serology for hepatitis B, hepatitis C virus, or human immunodeficiency virus

Sponsors & Collaborators

• Altavant Sciences GmbH: lead
• Altavant Sciences, Inc.: collaborator
• Parexel: collaborator

Study Sites (1)

California Clinical Trials Medical Group (CCTMG)

Glendale, California, 91206, United States

Location

MeSH Terms

Conditions

Pulmonary Arterial Hypertension

Interventions

rodatristat; BID protein, human

Condition Hierarchy (Ancestors)

Hypertension, Pulmonary; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multiple Ascending Dose

Study Record Dates

• First Submitted: August 2, 2021
• First Posted: October 4, 2021
• Study Start: October 1, 2021
• Primary Completion: March 30, 2022
• Study Completion: March 30, 2022
• Last Updated: July 13, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)