Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05065359
Other study ID # RVT-1201-1005
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date October 1, 2021
Est. completion date March 30, 2022

Study information

Verified date July 2022
Source Altavant Sciences GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy Japanese and Caucasian subjects. Two dose levels of rodatristat ethyl, 300 mg twice daily (BID) and 600 mg BID multiple doses (with a single dose lead in), will be explored in an ascending dose fashion with a safety review in between (Figure 1 below). Approximately 48 subjects will be enrolled in 4 cohorts.


Recruitment information / eligibility

Status Completed
Enrollment 47
Est. completion date March 30, 2022
Est. primary completion date March 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 55 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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 - b. Estimated glomerular filtration rate < 80 mL/min/1.73 m2 - c. Aspartate aminotransferase, alanine aminotransferase values greater than 1.5 x upper limit of normal. - d. Positive urine test for drugs of abuse - e. Positive alcohol test (breath, saliva, or urine) - Use of prescription or nonprescription drugs including high dose vitamins, dietary supplements (including St. John's Wort) within 7 days or 5 half-lives of the prescription or nonprescription drug (whichever was longer) prior to the first dose of IP product, unless in the opinion of the Investigator and Sponsor, the medication would not interfere with the study outcomes or compromise subject safety. - Subject unable to abstain from consumption of tryptophan-rich foods 48 hours prior to admission to the clinic through the Follow-up visit - Consumption of grapefruit or Seville oranges or their juices within the 7 days prior to dosing until collection of the final PK sample. - Use of medications associated with QT prolongation within 30 days prior to dosing and during the study. A list of prohibited medications is provided in an appendix to the protocol. - Subjects unable to abstain from alcohol for 72 hours prior to the start of dosing through collection of their final PK sample - Subjects with a clinical history of or current alcohol abuse defined as an average weekly intake of more than 21 units for males or 15 units for females (1 unit = 340 mL beer, 115 mL wine, or 43 mL spirits). - Subjects with a clinical history of or current illicit drug use which, in the opinion of the Investigator, would interfere with the subject's ability to complete the study and could compromise subject safety and/or the results of the study. - Subjects unable to abstain from caffeine, xanthine, or strenuous exercise for 72 hours prior to dosing until collection of their final PK sample. - Subjects who have smoked or used tobacco or nicotine-containing products or cannabidiol and related products (in all forms) within 3 months prior to the Screening visit and who are unwilling to refrain from cannabidiol and related products, smoking, tobacco use, or use of nicotine products and all for the entire duration of the study (through the Follow-up visit) - History of hypersensitivity to rodatristat ethyl, any its components, or any components in the placebo preparation. - Employed as site personnel directly involved with this study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Rodatristat Ethyl 300 mg BID
Tablets, oral, 300 mg, BID 14 days
Rodatristat Ethyl 600 mg BID
Tablets, oral, 600 mg, BID 14 days
Placebo
Tablets, oral, 0 mg, BID for 14 days

Locations

Country Name City State
United States California Clinical Trials Medical Group (CCTMG) Glendale California

Sponsors (3)

Lead Sponsor Collaborator
Altavant Sciences GmbH Altavant Sciences, Inc., Parexel

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety of rodatristat ethyl by incidence of adverse events Assessments of adverse events 21 days
Secondary Single dose AUC(0-8) Single dose area under the concentration time curve from time zero (predose-) extrapolated to infinity (AUC(0-8)) of rodatristat ethyl and metabolite(s). 21 days
Secondary Single dose AUC(0-t) Single dose area under the concentration time curve from time zero to the last detectable time point (AUC(0-t)) of rodatristat ethyl and metabolite(s). 21 days
Secondary Single dose Cmax Single dose maximum observed concentration (Cmax) of rodatristat ethyl and metabolite(s). 21 days
Secondary Single dose tmax Single dose time to maximum concentration (tmax) of rodatristat ethyl and metabolite(s). 21 days
Secondary Single dose t½ Single dose elimination half-life (t½) of rodatristat ethyl and metabolite(s). 21 days
Secondary Steady state tmax Steady-state tmax of rodatristat ethyl and metabolite(s). 21 days
Secondary Steady state Cmax Steady-state Cmax of rodatristat ethyl and metabolite(s). 21 days
Secondary Steady state Ct Steady-state concentration at end of dosing interval (Ct) of rodatristat ethyl and metabolite(s). 21 days
Secondary Steady state Cavg Steady-state average concentration at steady state (Cavg) of rodatristat ethyl and metabolite(s). 21 days
Secondary Steady state AUC(0-t) Steady-state area under the concentration-time curve over the dosing interval at steady-state (AUC(0-t)) of rodatristat ethyl and metabolite(s). 21 days
Secondary Steady state t½ Steady-state t½ of rodatristat ethyl and metabolite(s). 21 days
Secondary Pharmacodynamic assessment - change from baseline in 5-HIAA concentrations PD as assessed by the change from baseline in 5-hydroxyindoleacedtic acid (5-HIAA) concentrations (plasma and 24-hour urinary excretion) 21 days
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1