HealthyPhase 1NCT05933447
Thorough QT Study to Evaluate the Effect of Rodatristat Ethyl, Rodatristat and Its Major Metabolites on the Heart
A Phase 1 study testing Rodatristat Ethyl and Moxifloxacin in people with Healthy, run by Altavant Sciences GmbH at 1 site in United States.
Trial summary
To evaluate whether Rodatristat Ethyl prolongs the QTc interval when orally administered to healthy volunteers. 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 and Moxifloxacin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2023to 28 Jul 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
- Willing and able to give written informed consent and to comply with the requirements of the study for its duration.
- Healthy adult males or females aged 18 to 55 years, inclusive. As determined by the Investigator, healthy subjects are defined as individuals free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, cardiac monitoring, and clinical laboratory test results.
- 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.
- Female subjects of childbearing potential must agree to use contraception.
- Body mass index (BMI) within 18.0 kg/m2 to 33.0 kg/m2, inclusively.
Who cannot join
- Female who is lactating.
- Positive pregnancy test at the Screening visit or check-in or planning to become pregnant within the next 6 months.
- Pulse rate less than 40 beats per minute (bpm) or more than 100 bpm at the Screening visit or check-in.
- A sustained supine systolic blood pressure > 140 mm Hg or < 90 mmHg or a supine diastolic blood pressure > 90 mmHg or < 50 mmHg at the Screening visit, check-in, or prior to dosing.
- History of significant hypersensitivity to rodatristat ethyl, moxifloxacin, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
- 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 (including cholecystectomy), hematologic, renal, hepatic, bronchopulmonary, neurological, psychiatric, endocrine, immunologic, dermatologic or cardiovascular disease, including:
Show all 33Show fewer
- History of Gilbert's Syndrome
- History of depression
- History of any allergy that, in the opinion of the Investigator, contraindicates participation in the trial
- An uninterpretable or abnormal Screening ECG indicating a second or third degree atrioventricular block, presence of out-of-range cardiac interval (heart rate [HR] < 40 bpm, PR < 110 msec, PR > 200 msec, QRS < 60 msec, QRS >110 msec and Fridericia-corrected QT interval (QTcF) > 450 msec for males and > 470 msec for females) on the ECG at the Screening visit or other clinically significant ECG abnormalities, unless deemed non significant by an investigator.
- History of risk factors for torsades de pointes, including unexplained syncope, known long QT syndrome, heart failure, myocardial infarction, angina, or clinically significant abnormal laboratory assessments including hypokalemia, hypercalcemia, or hypomagnesemia. Subjects will also be excluded if there is a family history of long QT syndrome or Brugada syndrome.
- 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 the Screening visit or check-in that are confirmed by a repeat reading .
- Positive serology for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV)
- Estimated glomerular filtration rate < 80 mL/min/1.73 m2 at the Screening visit, calculated using the Cockcroft-Gault formula
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT) values greater than upper limit of normal (ULN). A single repeat measurement is allowed for eligibility determination
- Positive urine test for drugs of abuse at the Screening visit or check-in
- Positive alcohol test (breath) at the Screening visit or check-in
- Positive pregnancy test at the Screening visit or check-in
- Presence of unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
- 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 = 11 oz beer, 4 oz wine, or 1 oz spirits).
- Subjects with a clinical history of or current illicit drug use which, in the opinion of the Investigator, would interfere with the subjects ability to complete the study and could compromise subject safety and/or the results of the study.
- Any clinically significant illness, including viral syndromes, in the 28 days prior to dosing.
- Use of prescription or nonprescription drugs, (with exception of contraceptive and acetaminophen allowed), 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 is longer) prior to the first dose of study drug, through to the final Follow-up visit, unless in the opinion of the Investigator and Sponsor, the medication would not interfere with the study outcomes or compromise subject safety.
- Consumption of grapefruit and/or pomelo and Seville oranges or their juices within the 7 days prior to dosing and until collection of the final lab sample.
- Use of medications associated with QT prolongation within 30 days prior to dosing and during the study.
- Any other clinically significant abnormalities in laboratory test results at the Screening visit or check-in, or any other medical, psychological, or social condition that that would, in the opinion of an investigator, increase the subject's risk of participation, jeopardize complete participation in the study, or compromise interpretation of study data.
- Previous intake of rodatristat ethyl in the last 6 months before Day 1.
- Participation in another investigational drug, vaccine, or device study or treated with an investigational drug within 30 days or 5 half-lives, whichever is longer, before dosing, or 90 days for a biologic.
- Donation of plasma within 7 days prior to dosing or donation or loss of blood (excluding volume drawn at the Screening visit) of 50 mL to 499 mL of blood within 30 days or more than 499 mL within 56 days prior to dosing.
- Is an employee of the Investigator or study center with direct involvement in the proposed study or other studies under the direction of that Investigator or study center, as well as a family member of the employee or Investigator.
- 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 (through the Follow-up visit).
- Subjects unable to abstain from caffeine, xanthine, or strenuous exercise for 72 hours prior to dosing until collection of the final lab sample.
- Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C SSRS) administered at the Screening visit or prior to dosing.
Trial locations and contacts
1 site in 1 country.
United States1 site
Altasciences Clinical Kansas, Inc.
Overland Park, Kansas, 66212
About this study
Official title: A Randomized, Double-Blind and Nested Crossover (For Placebo and Moxifloxacin) Thorough QT Study to Evaluate the Effect of Rodatristat Ethyl, Rodatristat, and Its Major Metabolites on Cardiac Repolarization in Healthy Volunteers
To evaluate whether Rodatristat Ethyl prolongs the QTc interval when orally administered to healthy volunteers.
Read the detailed description
This is a Phase I, single-center, double blind, randomized, placebo- and positive-control, nested crossover study in approximately 64 healthy volunteers. This thorough QT/QTc study will be conducted to evaluate the effect of Rodatristat Ethyl on QT prolongation.
- Conditions
- Healthy
- Being tested
- Rodatristat Ethyl, Moxifloxacin, Placebo for Rodatristat, Placebo for Moxifloxacin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rodatristat EthylDrug
Oral, Tablet, 300 mg QD, 300 mg BID, 600 mg BID, 900 mg BID, 900 mg QD
MoxifloxacinDrug
Oral, Tablet, 400 mg QD
Placebo for RodatristatDrug
Oral, Tablet, O mg QD, 0 mg BID
Placebo for MoxifloxacinDrug
Oral, Tablet, 0 mg QD
| Study group | Role | What they receive |
|---|---|---|
| Rodatristat Ethyl | Experimental | Not described Receives: Drug: Rodatristat Ethyl |
| Moxifloxacin | Active comparator | Not described Receives: Drug: Moxifloxacin |
| Placebo for Rodatristat | Placebo comparator | Not described Receives: Drug: Placebo for Rodatristat |
| Placebo for Moxifloxacin | Placebo comparator | Not described Receives: Drug: Placebo for Moxifloxacin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of rodatristat ethyl, rodatristat, and its major metabolites on the Fredericia-corrected QT interval in healthy volunteers using concentration-QT analyses following administration of multiple doses of rodatristat ethyl
Measure change in baseline in QTcF
Measured: 20 Days
Secondary outcomes (3)
Evaluate the effect of multiple doses of rodatristat ethyl on other electrocardiogram (ECG) parameters
Measure change from baseline in heart rate
Measured: 55 Days
Evaluate the pharmacokinetics (PK) of rodatristat ethyl, rodatristat and it's major metabolites following multiple doses of rodatristat ethyl
Measure PK parameters time to maximum concentration (tmax)
Measured: 55 Days
Evaluate effect of multiple doses of rodatristat ethyl on plasma 5-hydroxyindoleacetic acid (5-HIAA)
Measure change from baseline in plasma 5-HIAA concentrations
Measured: 55 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start12 May 2023
- Primary completion28 Jul 2023
- Study completion28 Jul 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Altavant Sciences GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Altasciences Company Inc.
- Responsible party
- Sponsor
- Investigators
- Martin Kankam, MD, Principal investigator, Altasciences Company Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05933447
- Sponsor's protocol ID
- RVT-1201-1004
- Status last verified
- Jun 2023
- First submitted
- 3 May 2023
- Last updated
- 3 Oct 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 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind and Nested Crossover (For Placebo and Moxifloxacin) Thorough QT Study to Evaluate the Effect of Rodatristat Ethyl, Rodatristat, and Its Major Metabolites on Cardiac Repolarization in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT05933447
- Acronym / sponsor ID
- RVT-1201-1004
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Altavant Sciences GmbHIndustry (pharma, biotech, devices)
- Collaborators
- Altasciences Company Inc.
- Study start
- 12 May 2023 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 6 Jul 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.
To evaluate whether Rodatristat Ethyl prolongs the QTc interval when orally administered to healthy volunteers.
Detailed description
This is a Phase I, single-center, double blind, randomized, placebo- and positive-control, nested crossover study in approximately 64 healthy volunteers. This thorough QT/QTc study will be conducted to evaluate the effect of Rodatristat Ethyl on QT prolongation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Rodatristat Ethyl | Experimental | Drug: Rodatristat Ethyl |
| Moxifloxacin | Active comparator | Drug: Moxifloxacin |
| Placebo for Rodatristat | Placebo comparator | Drug: Placebo for Rodatristat |
| Placebo for Moxifloxacin | Placebo comparator | Drug: Placebo for Moxifloxacin |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Willing and able to give written informed consent and to comply with the requirements of the study for its duration.
- Healthy adult males or females aged 18 to 55 years, inclusive. As determined by the Investigator, healthy subjects are defined as individuals free from clinically significant illness or disease as determined by their medical history, physical examination, vital signs, cardiac monitoring, and clinical laboratory test results.
- 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.
- Female subjects of childbearing potential must agree to use contraception.
- Body mass index (BMI) within 18.0 kg/m2 to 33.0 kg/m2, inclusively.
Key exclusion criteria (33 listed)
- Female who is lactating.
- Positive pregnancy test at the Screening visit or check-in or planning to become pregnant within the next 6 months.
- Pulse rate less than 40 beats per minute (bpm) or more than 100 bpm at the Screening visit or check-in.
- A sustained supine systolic blood pressure > 140 mm Hg or < 90 mmHg or a supine diastolic blood pressure > 90 mmHg or < 50 mmHg at the Screening visit, check-in, or prior to dosing.
- History of significant hypersensitivity to rodatristat ethyl, moxifloxacin, or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
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 EthylOral, Tablet, 300 mg QD, 300 mg BID, 600 mg BID, 900 mg BID, 900 mg QD | Drug | Rodatristat Ethyl |
| MoxifloxacinOral, Tablet, 400 mg QD | Drug | Moxifloxacin |
| Placebo for RodatristatOral, Tablet, O mg QD, 0 mg BID | Drug | Placebo for Rodatristat |
| Placebo for MoxifloxacinOral, Tablet, 0 mg QD | Drug | Placebo for Moxifloxacin |
Primary outcome
Evaluate the effect of rodatristat ethyl, rodatristat, and its major metabolites on the Fredericia-corrected QT interval in healthy volunteers using concentration-QT analyses following administration of multiple doses of rodatristat ethyl
Time frame: 20 Days
Measure change in baseline in QTcF
3 secondary outcomes
Evaluate the effect of multiple doses of rodatristat ethyl on other electrocardiogram (ECG) parameters
Time frame: 55 Days
Evaluate the pharmacokinetics (PK) of rodatristat ethyl, rodatristat and it's major metabolites following multiple doses of rodatristat ethyl
Time frame: 55 Days
Evaluate effect of multiple doses of rodatristat ethyl on plasma 5-hydroxyindoleacetic acid (5-HIAA)
Time frame: 55 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 3 Oct 2023.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Martin Kankam, MD principal investigator
Altasciences Company Inc.
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 and Moxifloxacin 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 33 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 3 Oct 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?
Evaluate the effect of rodatristat ethyl, rodatristat, and its major metabolites on the Fredericia-corrected QT interval in healthy volunteers using concentration-QT analyses following administration of multiple doses of rodatristat ethyl (time frame: 20 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 3 Oct 2023.