HealthyPhase 1NCT05065359
Multiple-Ascending Dose in Japanese Patients Bridging Study
A Phase 1 study testing Rodatristat Ethyl 300 mg BID and Rodatristat Ethyl 600 mg BID in people with Healthy, run by Altavant Sciences GmbH at 1 site in United States.
Trial summary
This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy Japanese and Caucasian subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rodatristat Ethyl 300 mg BID and Rodatristat Ethyl 600 mg BID
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2021to 30 Mar 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 30Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
California Clinical Trials Medical Group (CCTMG)
Glendale, California, 91206
About this study
Official title: A Randomized, Double-Blinded, Placebo-Controlled, MultipleAscending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rodatristat Ethyl in Healthy Japanese and Caucasian Subjects
This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy Japanese and Caucasian subjects.
Read the detailed 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.
- Conditions
- Healthy
- Being tested
- Rodatristat Ethyl 300 mg BID, Rodatristat Ethyl 600 mg BID, Placebo
- Keywords
- Pulmonary Arterial Hypertension, PAH
- Medical subject headings
- Pulmonary Arterial Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rodatristat Ethyl 300 mg BIDDrug
Tablets, oral, 300 mg, BID 14 days
Rodatristat Ethyl 600 mg BIDDrug
Tablets, oral, 600 mg, BID 14 days
PlaceboDrug
Tablets, oral, 0 mg, BID for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Rodatristat Ethyl 300 mg BID - Japanese subjects | Experimental | Not described Receives: Drug: Rodatristat Ethyl 300 mg BID |
| Placebo match for Rodatristat Ethyl 300 mg BID - Japanese subjects | Placebo comparator | Not described Receives: Drug: Placebo |
| Rodatristat Ethyl 300 mg BID - Caucasian subjects | Experimental | Not described Receives: Drug: Rodatristat Ethyl 300 mg BID |
| Placebo match for Rodatristat Ethyl 300 mg BID - Caucasian subjects | Placebo comparator | Not described Receives: Drug: Placebo |
| Rodatristat Ethyl 600 mg BID - Japanese subjects | Experimental | Not described Receives: Drug: Rodatristat Ethyl 600 mg BID |
| Placebo match for Rodatristat Ethyl 600 mg BID - Japanese subjects | Placebo comparator | Not described Receives: Drug: Placebo |
| Rodatristat Ethyl 600 mg BID - Caucasian subjects | Experimental | Not described Receives: Drug: Rodatristat Ethyl 600 mg BID |
| Placebo match for Rodatristat Ethyl 600 mg BID - Caucasian subjects | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of rodatristat ethyl by incidence of adverse events
Assessments of adverse events
Measured: 21 days
Secondary outcomes (12)
Single dose AUC(0-∞)
Single dose area under the concentration time curve from time zero (predose-) extrapolated to infinity (AUC(0-∞)) of rodatristat ethyl and metabolite(s).
Measured: 21 days
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).
Measured: 21 days
Single dose Cmax
Single dose maximum observed concentration (Cmax) of rodatristat ethyl and metabolite(s).
Measured: 21 days
Single dose tmax
Single dose time to maximum concentration (tmax) of rodatristat ethyl and metabolite(s).
Measured: 21 days
Single dose t½
Single dose elimination half-life (t½) of rodatristat ethyl and metabolite(s).
Measured: 21 days
Steady state tmax
Steady-state tmax of rodatristat ethyl and metabolite(s).
Measured: 21 days
Steady state Cmax
Steady-state Cmax of rodatristat ethyl and metabolite(s).
Measured: 21 days
Steady state Cτ
Steady-state concentration at end of dosing interval (Cτ) of rodatristat ethyl and metabolite(s).
Measured: 21 days
Steady state Cavg
Steady-state average concentration at steady state (Cavg) of rodatristat ethyl and metabolite(s).
Measured: 21 days
Steady state AUC(0-τ)
Steady-state area under the concentration-time curve over the dosing interval at steady-state (AUC(0-τ)) of rodatristat ethyl and metabolite(s).
Measured: 21 days
Steady state t½
Steady-state t½ of rodatristat ethyl and metabolite(s).
Measured: 21 days
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)
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start1 Oct 2021
- Primary completion30 Mar 2022
- Study completion30 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multiple Ascending Dose
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altavant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parexel
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05065359
- Sponsor's protocol ID
- RVT-1201-1005
- Status last verified
- Jul 2022
- First submitted
- 2 Aug 2021
- Last updated
- 13 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blinded, Placebo-Controlled, MultipleAscending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Rodatristat Ethyl in Healthy Japanese and Caucasian Subjects
- ClinicalTrials.gov ID
- NCT05065359
- Acronym / sponsor ID
- RVT-1201-1005
- Conditions
- Healthy
- Keywords
- Pulmonary Arterial Hypertension, PAH
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Altavant Sciences GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Parexel
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 30 Mar 2022 (actual)
- Study completion
- 30 Mar 2022 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized, placebo-controlled, multiple-ascending dose study in healthy Japanese and Caucasian subjects.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 8
- Model description
- Multiple Ascending Dose
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (30 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rodatristat Ethyl 300 mg BIDTablets, oral, 300 mg, BID 14 days | Drug | Rodatristat Ethyl 300 mg BID - Caucasian subjects, Rodatristat Ethyl 300 mg BID - Japanese subjects |
| Rodatristat Ethyl 600 mg BIDTablets, oral, 600 mg, BID 14 days | Drug | Rodatristat Ethyl 600 mg BID - Caucasian subjects, Rodatristat Ethyl 600 mg BID - Japanese subjects |
| PlaceboTablets, oral, 0 mg, BID for 14 days | Drug | 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 |
Primary outcome
Safety of rodatristat ethyl by incidence of adverse events
Time frame: 21 days
Assessments of adverse events
12 secondary outcomes
Single dose AUC(0-∞)
Time frame: 21 days
Single dose AUC(0-t)
Time frame: 21 days
Single dose Cmax
Time frame: 21 days
Single dose tmax
Time frame: 21 days
Single dose t½
Time frame: 21 days
Steady state tmax
Time frame: 21 days
Steady state Cmax
Time frame: 21 days
Steady state Cτ
Time frame: 21 days
Steady state Cavg
Time frame: 21 days
Steady state AUC(0-τ)
Time frame: 21 days
Steady state t½
Time frame: 21 days
Pharmacodynamic assessment - change from baseline in 5-HIAA concentrations
Time frame: 21 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rodatristat Ethyl 300 mg BID and Rodatristat Ethyl 600 mg BID in people with Healthy, run by Altavant Sciences GmbH at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of rodatristat ethyl by incidence of adverse events (time frame: 21 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2022.