A Single and Multiple Dose of Rodatristat Ethyl in Healthy Adult Subjects to Evaluate the Effect of Food and Safety

NCT05684640 | Completed Phase 1 FDA Drug

• 1 other identifier: RVT-1201-1006
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single and multiple dose food effect study of rodatristat ethyl in healthy subjects

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Part 1 will evaluate the effect of a high-fat meal on the PK of rodatristat ethyl, rodatristat, and its metabolite(s) following single-dose administration of a rodatristat ethyl 600 mg dose

  Measure Rodatristat, rodatristat ethyl, and its metabolite(s): Maximum plasma concentration Cmax, area under the plasma concentration-time curve from time zero (predose) to the last detectable time point.

  6 Days

• Part 2 will assess the PK of rodatristat ethyl, rodatristat, and metabolite(s) following multiple repeat doses of rodatristat ethyl at a supratherapeutic level

  Measure PK parameters, area under the concentration time curve over the dosing interval.

  11 Days

Secondary Outcomes (3)

• Part 1 will also evaluate the effect of a high-fat meal on other PK parameters of rodatristat ethyl, rodatristat, and its metabolites

  6 Day

• Part 1 will also evaluate the effect of a high-fat meal on other PK parameters of rodatristat ethyl, rodatristat, and its metabolites

  6 Day

• Part 2 will also assess the effect of a supratherapeutic dose of rodatristat ethyl on plasma 5 hydroxyindoleacetic acid (5 HIAA) concentrations

  11 Days

Study Arms (2)

Rodatristat ethyl

EXPERIMENTAL

Part One: is 600 QD

Drug: Rodatristat Ethyl

Placebo

PLACEBO COMPARATOR

Part Two: Placebo match for Rodatristat ethyl

Drug: Rodatristat Ethyl; Drug: Placebo

Interventions

Rodatristat Ethyl DRUG

Tablets, Oral, 600mg, QD

Placebo; Rodatristat ethyl

Placebo DRUG

Tablets, Oral, 0mg, BID

Placebo

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 study drug, 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 4 weeks after the last dose of study drug.
• Body mass index (BMI) ≥ 18 kg/m2 and ≤ 30 kg/m2.
• Willing and able to give written informed consent and to comply with the requirements of the study for its duration.

You may not qualify if:

• As determined by the Investigator, 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, including
• History of Gilbert's Syndrome
• History of depression
• History of any allergy that, in the opinion of the Investigator, contraindicates participation in the trial
• Positive pregnancy test at Screening or Check-in.
• 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 starting study drug.
• Participation in an investigational drug, vaccine, or device study within 30 days before study drug administration or 90 days for a biologic study.
• Clinically significant ECG abnormalities.
• 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) at Screening or prior to starting study drug.
• Clinically significant abnormalities in laboratory test results, as determined by the Investigator, (including hepatic and renal panels, complete blood count, coagulation, chemistry panel, and urinalysis) at Screening or Check-in.
• Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
• Estimated glomerular filtration rate \< 90 mL/min/1.73 m2 at Screening, calculated using the Modification of Diet in Renal Disease (MDRD) formula.
• Aspartate aminotransferase (AST), alanine aminotransferase (ALT) values greater than upper limit of normal (ULN).
• Positive urine test for drugs of abuse at Screening or Check-in.
• Positive alcohol test (breath, saliva, or urine) at Screening or Check-in.

Sponsors & Collaborators

• Altavant Sciences GmbH: lead
• PPD Development, LP: collaborator

Study Sites (1)

PPD Development

Austin, Texas, 78744, United States

Location

MeSH Terms

Interventions

rodatristat

Study Officials

• Thomas Hunt, MD

  PPD Development, LP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: There are 2 parts to the study. Part one is an open label parallel study and Part 2 is a randomized double-blind placebo controlled study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single and multiple dose

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: January 13, 2023
• Study Start: September 29, 2022
• Primary Completion: January 17, 2023
• Study Completion: January 17, 2023
• Last Updated: January 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)