HealthyPhase 1NCT05684640
A Single and Multiple Dose of Rodatristat Ethyl in Healthy Adult Subjects to Evaluate the Effect of Food and Safety
A Phase 1 study testing Rodatristat Ethyl in people with Healthy, run by Altavant Sciences GmbH at 1 site in United States.
Trial summary
This is a single and multiple dose food effect study of rodatristat ethyl in healthy 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Sep 2022to 17 Jan 2023
- 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 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.
Who cannot join
- 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.
Show all 25Show fewer
- 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.
- Positive pregnancy test at Screening or Check-in.
- Use of prescription or nonprescription drugs, (with exception of contraceptive and acetaminophen allowance), including high dose vitamins, dietary supplements (including St. John's Wort) within 14 days or 5 half lives of the prescription or nonprescription drug (whichever was longer) prior to the first dose of study drug, through to the final 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.
- Subjects unable to abstain from alcohol for 72 hours prior to the start of dosing through collection of the 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.
- Subjects unable to abstain from caffeine, xanthine, or strenuous exercise for 72 hours prior to dosing.
- Subjects who have smoked or used tobacco- or nicotine containing products within 3 months prior to the Screening visit and who are unwilling to refrain from smoking, tobacco use, or use of nicotine products for the entire duration of the study.
- Employed as site personnel directly involved with this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single and Multiple Dose Study of Rodatristat Ethyl in Healthy Subjects to Evaluate the Effect of Food, and the Safety, Tolerability, and Pharmacokinetics of a Supratherapeutic Dose of Rodatristat Ethyl
This is a single and multiple dose food effect study of rodatristat ethyl in healthy subjects
Read the detailed description
This is a two-part Phase 1 study. Part 1 is a single dose, randomized, open label, parallel, single site study designed to evaluate the effect of a high fat meal on the PK of rodatristat ethyl, rodatristat and metabolite(s). Part 2 is a randomized double-blind, placebo-controlled study to evaluate the safety and tolerability of repeat supratherapeutic dose of rodatristat ethyl when administered twice daily with a standard meal.
- Conditions
- Healthy
- Being tested
- Rodatristat Ethyl, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rodatristat EthylDrug
Tablets, Oral, 600mg, QD
PlaceboDrug
Tablets, Oral, 0mg, BID
| Study group | Role | What they receive |
|---|---|---|
| Rodatristat ethyl | Experimental | Part One: is 600 QD Receives: Drug: Rodatristat Ethyl |
| Placebo | Placebo comparator | Part Two: Placebo match for Rodatristat ethyl Receives: Drug: Rodatristat Ethyl; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measure PK parameters: time to maximum concentration (tmax).
Measured: 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
Measure elimination of half life (t 1/2)
Measured: 6 Day
Part 2 will also assess the effect of a supratherapeutic dose of rodatristat ethyl on plasma 5 hydroxyindoleacetic acid (5 HIAA) concentrations
Measure changes from baseline in plasma 5-HIAA concentrations from Baseline
Measured: 11 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2023
- Study start29 Sep 2022
- Primary completion17 Jan 2023
- Study completion17 Jan 2023
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
- Single and multiple dose
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altavant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Responsible party
- Sponsor
- Investigators
- Thomas Hunt, MD, Principal investigator, PPD Development, LP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05684640
- Sponsor's protocol ID
- RVT-1201-1006
- Status last verified
- Jan 2023
- First submitted
- 7 Nov 2022
- Last updated
- 27 Jan 2023
- 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 27 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single and Multiple Dose Study of Rodatristat Ethyl in Healthy Subjects to Evaluate the Effect of Food, and the Safety, Tolerability, and Pharmacokinetics of a Supratherapeutic Dose of Rodatristat Ethyl
- ClinicalTrials.gov ID
- NCT05684640
- Acronym / sponsor ID
- RVT-1201-1006
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Altavant Sciences GmbHIndustry (pharma, biotech, devices)
- Collaborators
- PPD Development, LP
- Study start
- 29 Sep 2022 (actual)
- Primary completion
- 17 Jan 2023 (actual)
- Study completion
- 17 Jan 2023 (actual)
- First posted
- 13 Jan 2023 (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 is a single and multiple dose food effect study of rodatristat ethyl in healthy subjects
Detailed description
This is a two-part Phase 1 study. Part 1 is a single dose, randomized, open label, parallel, single site study designed to evaluate the effect of a high fat meal on the PK of rodatristat ethyl, rodatristat and metabolite(s). Part 2 is a randomized double-blind, placebo-controlled study to evaluate the safety and tolerability of repeat supratherapeutic dose of rodatristat ethyl when administered twice daily with a standard meal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Single and multiple dose
| Arm | Type | Receives |
|---|---|---|
| Rodatristat ethyl | Experimental | Drug: Rodatristat EthylPart One: is 600 QD |
| Placebo | Placebo comparator | Drug: Rodatristat Ethyl, Drug: PlaceboPart Two: Placebo match for Rodatristat ethyl |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 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 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.
Key exclusion criteria (25 listed)
- 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
- 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.
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 EthylTablets, Oral, 600mg, QD | Drug | Placebo, Rodatristat ethyl |
| PlaceboTablets, Oral, 0mg, BID | Drug | Placebo |
Primary outcome
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
Time frame: 6 Days
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.
Part 2 will assess the PK of rodatristat ethyl, rodatristat, and metabolite(s) following multiple repeat doses of rodatristat ethyl at a supratherapeutic level
Time frame: 11 Days
Measure PK parameters, area under the concentration time curve over the dosing interval.
3 secondary outcomes
Part 1 will also evaluate the effect of a high-fat meal on other PK parameters of rodatristat ethyl, rodatristat, and its metabolites
Time frame: 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
Time frame: 6 Day
Part 2 will also assess the effect of a supratherapeutic dose of rodatristat ethyl on plasma 5 hydroxyindoleacetic acid (5 HIAA) concentrations
Time frame: 11 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 27 Jan 2023.
- 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.
Thomas Hunt, MD principal investigator
PPD Development, LP
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 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 5 inclusion and 25 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 27 Jan 2023. 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?
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 (time frame: 6 Days). The study lists 2 primary outcomes in all. 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 27 Jan 2023.