HealthyPhase 1NCT05287360
A Study Comparing Four Different Rivoceranib Tablets in Healthy Participants
A Phase 1 study testing Rivoceranib in people with Healthy, run by Elevar Therapeutics at 1 site in United States.
Trial summary
The main purpose of this trial is to compare a single dose of 4 different rivoceranib tablets in healthy adult participants. 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?
- Rivoceranib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Dec 2021to 24 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
- Participants must have a body mass index from 18.5 to 32.0 kilograms (kg)/meter squared (inclusive) and a weight of ≥ 50 kg at Screening.
- Participants must be able to provide informed consent after risks and benefits have been explained. Participants must be capable of understanding, able to sign a written informed consent, and willing to comply with the protocol requirements.
- Participants must agree to discontinue intake of beverages and foods known to interfere with cytochrome P450 (CYP) metabolic enzymes such as: grapefruit- and quinine-containing food and beverages (for example, tonic water, bitter lemon), orange juice, pomelos, cranberry, pomegranate, starfruit, Seville oranges (or marmalade made from them), garlic supplements or licorice, within 14 days prior to first dosing.
- Participants must be in general good health as determined by the principal investigator (PI), based on pre-study medical and surgical history, physical examination, and clinical laboratory tests.
- Participants must have normal blood pressure at Screening: systolic blood pressure < 130 millimeters of mercury (mmHg) and diastolic blood pressure < 85 mmHg.
- Participants must have no clinically significant laboratory test results (≤ 1.5 x upper limit of normal for serum aspartate aminotransferase and alanine aminotransferase) at Screening.
- Participants must have no clinically significant laboratory test results for prothrombin time, activated partial thromboplastin time, and international normalized ratio (> 20% outside the normal ranges) at Screening and Check-in.
Who cannot join
- Participants who have participated in any investigational study within 30 days or 5 half-lives of the test drug's biologic activity, whichever is longer, prior to the first dosing.
- Participants with any medical or surgical condition that may interfere with the absorption, distribution, or metabolism of the study drugs.
- Participants who have a history of hypersensitivity to rivoceranib or any of its excipients.
- Participants who are unwilling or unable to avoid xanthine- and caffeine-containing drinks (including many soft drinks, energy drinks, coffee, and tea) and foods (such as chocolate or coffee flavored) from 72 hours prior to first dosing.
- Participants unable to refrain from or anticipate the use of:
- any non-prescription medications, herbal remedies, or vitamin supplements within 14 days prior to the first dosing
Show all 9Show fewer
- any investigational drugs and prescription medications within 28 days prior to the first dosing. Use of any drugs or herbal remedies known to be significant inhibitors or inducers of CYP 3A4 and 2D6 enzymes for 28 days prior to the first dosing
- appropriate sources (for example, Flockhart Table) will be consulted to confirm lack of PK/pharmacodynamic interaction with study drugs
- Participants with corrected QT interval by Fridericia's formula > 460 microseconds or have clinically significant electrocardiogram findings, in the opinion of the PI, at Screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Bioequivalence of Four Formulations of Oral Rivoceranib Tablets in Healthy Subjects
The main purpose of this trial is to compare a single dose of 4 different rivoceranib tablets in healthy adult participants.
Read the detailed description
Participants will be randomized to 1 of 4 treatment sequences (1-4). Each participant will participate in 4 treatment periods. One formulation of rivoceranib will be administered per treatment period. Blood samples will be collected predose and up to 120 hours postdose to evaluate the pharmacokinetics (PK) of rivoceranib and its major metabolites.
- Conditions
- Healthy
- Being tested
- Rivoceranib
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivoceranibDrug
Also called Rivoceranib Mesylate, Apatinib Mesylate
Rivoceranib will be supplied as film-coated tablets for oral administration as 4 different formulations: Formulation 1, 3, and 4 = 250 milligrams; Formulation 2 = 200 milligrams.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Sequence 1 | Experimental | Participants will receive rivoceranib on Day 1 of each period as a single dose under fasted conditions as follows:
Period 1: Formulation 1; Period 2: Formulation 2; Period 3: Formulation 3; Period 4: Formulation 4
There will be a washout period of 5 days between each dosing. Receives: Drug: Rivoceranib |
| Treatment Sequence 2 | Experimental | Participants will receive rivoceranib on Day 1 of each period as a single dose under fasted conditions as follows:
Period 1: Formulation 2; Period 2: Formulation 4; Period 3: Formulation 1; Period 4: Formulation 3
There will be a washout period of 5 days between each dosing. Receives: Drug: Rivoceranib |
| Treatment Sequence 3 | Experimental | Participants will receive rivoceranib on Day 1 of each period as a single dose under fasted conditions as follows:
Period 1: Formulation 3; Period 2: Formulation 1; Period 3: Formulation 4; Period 4: Formulation 2
There will be a washout period of 5 days between each dosing. Receives: Drug: Rivoceranib |
| Treatment Sequence 4 | Experimental | Participants will receive rivoceranib on Day 1 of each period as a single dose under fasted conditions as follows:
Period 1: Formulation 4; Period 2: Formulation 3; Period 3: Formulation 2; Period 4: Formulation 1
There will be a washout period of 5 days between each dosing. Receives: Drug: Rivoceranib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under The Concentration-time Curve From Time 0 To The Last Observed Non-zero Concentration (AUC0-t) For Plasma Rivoceranib And Its Major Metabolites
Measured: 0 (predose) up to 120 hours postdose
Area Under The Concentration-time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) For Plasma Rivoceranib And Its Major Metabolites
Measured: 0 (predose) up to 120 hours postdose
Maximum Observed Concentration (Cmax) For Plasma Rivoceranib And Its Major Metabolites
Measured: 0 (predose) up to 120 hours postdose
Secondary outcomes (7)
Percent Of AUC0-inf Extrapolated (AUC%extrap) For Plasma Rivoceranib And Its Major Metabolites
Measured: 0 (predose) up to 120 hours postdose
Apparent Volume Of Distribution During The Terminal Elimination Phase After Oral (Extravascular) Administration (Vz/F) For Plasma Rivoceranib
Measured: 0 (predose) up to 120 hours postdose
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) For Plasma Rivoceranib
Measured: 0 (predose) up to 120 hours postdose
Apparent First-order Terminal Elimination Half-life (t½) For Plasma Rivoceranib And Its Major Metabolites
Measured: 0 (predose) up to 120 hours postdose
Apparent First-order Terminal Elimination Rate Constant (Kel) For Plasma Rivoceranib And Its Major Metabolites
Measured: 0 (predose) up to 120 hours postdose
Time Of Observed Cmax (Tmax) For Plasma Rivoceranib And Its Major Metabolites
Measured: 0 (predose) up to 120 hours postdose
Participants Experiencing Treatment-emergent Adverse Events
Measured: Day 1 through Follow-up (14 days after the last dose of study drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2022
- Study start30 Dec 2021
- Primary completion16 Mar 2022
- Study completion24 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elevar Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05287360
- Sponsor's protocol ID
- RM-113
- Status last verified
- Apr 2022
- First submitted
- 10 Mar 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Open-label, Single-dose, Crossover Study to Evaluate the Bioequivalence of Four Formulations of Oral Rivoceranib Tablets in Healthy Subjects
- ClinicalTrials.gov ID
- NCT05287360
- Acronym / sponsor ID
- RM-113
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Elevar TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 16 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 18 Mar 2022 (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.
The main purpose of this trial is to compare a single dose of 4 different rivoceranib tablets in healthy adult participants.
Detailed description
Participants will be randomized to 1 of 4 treatment sequences (1-4). Each participant will participate in 4 treatment periods. One formulation of rivoceranib will be administered per treatment period. Blood samples will be collected predose and up to 120 hours postdose to evaluate the pharmacokinetics (PK) of rivoceranib and its major metabolites.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Treatment Sequence 1 | Experimental | Drug: RivoceranibParticipants will receive rivoceranib on Day 1 of each period as a single dose under fasted conditions as follows: Period 1: Formulation 1; Period 2: Formulation 2; Period 3: Formulation 3; Period 4: Formulation 4 There will be a washout period of 5 days between each dosing. |
| Treatment Sequence 2 | Experimental | Drug: RivoceranibParticipants will receive rivoceranib on Day 1 of each period as a single dose under fasted conditions as follows: Period 1: Formulation 2; Period 2: Formulation 4; Period 3: Formulation 1; Period 4: Formulation 3 There will be a washout period of 5 days between each dosing. |
| Treatment Sequence 3 | Experimental | Drug: RivoceranibParticipants will receive rivoceranib on Day 1 of each period as a single dose under fasted conditions as follows: Period 1: Formulation 3; Period 2: Formulation 1; Period 3: Formulation 4; Period 4: Formulation 2 There will be a washout period of 5 days between each dosing. |
| Treatment Sequence 4 | Experimental | Drug: RivoceranibParticipants will receive rivoceranib on Day 1 of each period as a single dose under fasted conditions as follows: Period 1: Formulation 4; Period 2: Formulation 3; Period 3: Formulation 2; Period 4: Formulation 1 There will be a washout period of 5 days between each dosing. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Participants must have a body mass index from 18.5 to 32.0 kilograms (kg)/meter squared (inclusive) and a weight of ≥ 50 kg at Screening.
- Participants must be able to provide informed consent after risks and benefits have been explained. Participants must be capable of understanding, able to sign a written informed consent, and willing to comply with the protocol requirements.
- Participants must agree to discontinue intake of beverages and foods known to interfere with cytochrome P450 (CYP) metabolic enzymes such as: grapefruit- and quinine-containing food and beverages (for example, tonic water, bitter lemon), orange juice, pomelos, cranberry, pomegranate, starfruit, Seville oranges (or marmalade made from them), garlic supplements or licorice, within 14 days prior to first dosing.
- Participants must be in general good health as determined by the principal investigator (PI), based on pre-study medical and surgical history, physical examination, and clinical laboratory tests.
- Participants must have normal blood pressure at Screening: systolic blood pressure < 130 millimeters of mercury (mmHg) and diastolic blood pressure < 85 mmHg.
Key exclusion criteria (9 listed)
- Participants who have participated in any investigational study within 30 days or 5 half-lives of the test drug's biologic activity, whichever is longer, prior to the first dosing.
- Participants with any medical or surgical condition that may interfere with the absorption, distribution, or metabolism of the study drugs.
- Participants who have a history of hypersensitivity to rivoceranib or any of its excipients.
- Participants who are unwilling or unable to avoid xanthine- and caffeine-containing drinks (including many soft drinks, energy drinks, coffee, and tea) and foods (such as chocolate or coffee flavored) from 72 hours prior to first dosing.
- Participants unable to refrain from or anticipate the use of:
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 |
|---|---|---|
| RivoceranibAlso: Rivoceranib Mesylate, Apatinib MesylateRivoceranib will be supplied as film-coated tablets for oral administration as 4 different formulations: Formulation 1, 3, and 4 = 250 milligrams; Formulation 2 = 200 milligrams. | Drug | Treatment Sequence 1, Treatment Sequence 2, Treatment Sequence 3, Treatment Sequence 4 |
Primary outcome
Area Under The Concentration-time Curve From Time 0 To The Last Observed Non-zero Concentration (AUC0-t) For Plasma Rivoceranib And Its Major Metabolites
Time frame: 0 (predose) up to 120 hours postdose
Area Under The Concentration-time Curve From Time 0 Extrapolated To Infinity (AUC0-inf) For Plasma Rivoceranib And Its Major Metabolites
Time frame: 0 (predose) up to 120 hours postdose
Maximum Observed Concentration (Cmax) For Plasma Rivoceranib And Its Major Metabolites
Time frame: 0 (predose) up to 120 hours postdose
7 secondary outcomes
Percent Of AUC0-inf Extrapolated (AUC%extrap) For Plasma Rivoceranib And Its Major Metabolites
Time frame: 0 (predose) up to 120 hours postdose
Apparent Volume Of Distribution During The Terminal Elimination Phase After Oral (Extravascular) Administration (Vz/F) For Plasma Rivoceranib
Time frame: 0 (predose) up to 120 hours postdose
Apparent Total Plasma Clearance After Oral (Extravascular) Administration (CL/F) For Plasma Rivoceranib
Time frame: 0 (predose) up to 120 hours postdose
Apparent First-order Terminal Elimination Half-life (t½) For Plasma Rivoceranib And Its Major Metabolites
Time frame: 0 (predose) up to 120 hours postdose
Apparent First-order Terminal Elimination Rate Constant (Kel) For Plasma Rivoceranib And Its Major Metabolites
Time frame: 0 (predose) up to 120 hours postdose
Time Of Observed Cmax (Tmax) For Plasma Rivoceranib And Its Major Metabolites
Time frame: 0 (predose) up to 120 hours postdose
Participants Experiencing Treatment-emergent Adverse Events
Time frame: Day 1 through Follow-up (14 days after the last dose of study drug)
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 18 Apr 2022.
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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 Rivoceranib in people with Healthy, run by Elevar Therapeutics 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 9 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 18 Apr 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. 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?
Area Under The Concentration-time Curve From Time 0 To The Last Observed Non-zero Concentration (AUC0-t) For Plasma Rivoceranib And Its Major Metabolites (time frame: 0 (predose) up to 120 hours postdose). The study lists 3 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 18 Apr 2022.