Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R44CA268392 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Quotient Sciences | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The objectives of this trial are:
The first in human study is intended to evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers, and to determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RVP-001 group | Experimental | 4 Cohorts of 6 subjects each will receive RVP-001 at doses of 2, 4, 7 and 12 mg Mn/kg. |
|
| Placebo group | Placebo Comparator | 4 Cohorts of 2 subjects each will receive placebo (saline). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RVP-001 | Drug | Intravenous administration of RVP-001 |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic (PK) Parameter Cmax | Cmax = maximum observed blood plasma concentration of RVP-001 | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
| PK Parameter Tmax | tmax = time of maximum observed plasma concentration of RVP-001 | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
| PK Parameter t1/2 | t1/2 = terminal elimination half-life of RVP-001 | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
| PK Parameter Cl | Cl = total body clearance calculated after a single IV administration of RVP-001 | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
| PK Parameter Vd | Vd = volume of distribution calculated after a single IV administration of RVP-001 | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
| Measure | Description | Time Frame |
|---|---|---|
| % RVP-001 Dose Excreted | mean % of RVP-001 excreted from urine from 0 -120 hours post dose | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Srinivasan Mukundan, MD | Reveal Pharmaceuticals | Study Director |
| Jeffrey Levy, MD | Quotient Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences | Miami | Florida | 33126 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38038701 | Derived | Caravan P. Divalent Manganese Complexes as Potential Replacements for Gadolinium-Based Contrast Agents. Invest Radiol. 2024 Feb 1;59(2):187-196. doi: 10.1097/RLI.0000000000001053. Epub 2023 Dec 1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | RVP-001: 2 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 2 mg Mn/kg administered via automated injection pump. |
| FG001 | RVP-001: 4 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 4 mg Mn/kg administered via automated injection pump. |
| FG002 | RVP-001: 7 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 7 mg Mn/kg administered via automated injection pump. |
| FG003 | RVP-001: 12 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 12 mg Mn/kg administered via automated injection pump. |
| FG004 | Placebo Group | Placebo Placebo: Intravenous administration of saline placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | RVP-001: 2 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 2 mg Mn/kg administered via automated injection pump |
| BG001 | RVP-001: 4 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 4 mg Mn/kg administered via automated injection pump |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pharmacokinetic (PK) Parameter Cmax | Cmax = maximum observed blood plasma concentration of RVP-001 | All subjects who received at least one dose of RVP-001 and had sufficient data to calculate at least one PK parameter | Posted | Geometric Mean | Geometric Coefficient of Variation | nmol/mL | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
|
Adverse events were collected from signing of consent to last study visit - approximately 7 days.
Adverse events were defined as "Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research."
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | RVP-001: 2 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 2 mg Mn/kg administered via automated injection pump |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jeffrey Levy | Quotient Sciences | +44 (0)115 974 9000 | jeffrey.levy@quotientsciences.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2022 | Jul 22, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | Intravenous administration of saline placebo |
|
|
| BG002 | RVP-001: 7 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 7 mg Mn/kg administered via automated injection pump |
| BG003 | RVP-001: 12 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 12 mg Mn/kg administered via automated injection pump |
| BG004 | Placebo Group | 8 subjects received placebo (saline) administered via automated injection pump |
| BG005 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Body Weight | Mean | Full Range | Kg |
|
| Height | Mean | Full Range | cm |
|
| BMI | Mean | Full Range | kg/m^2 |
|
| OG002 | RVP-001: 7 mn Mn/kg | 6 subjects received RVP-001 in a single dose of 7 mg Mn/kg administered via automated injection pump. |
| OG003 | RVP-001: 12 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 12 mg Mn/kg administered via automated injection pump. |
|
|
| Primary | PK Parameter Tmax | tmax = time of maximum observed plasma concentration of RVP-001 | Posted | Geometric Mean | Full Range | hours | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
|
|
|
| Primary | PK Parameter t1/2 | t1/2 = terminal elimination half-life of RVP-001 | All subjects who received at least one dose of RVP-001 and had sufficient data to calculate at least one PK parameter | Posted | Geometric Mean | Geometric Coefficient of Variation | hours | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
|
|
|
| Primary | PK Parameter Cl | Cl = total body clearance calculated after a single IV administration of RVP-001 | Posted | Geometric Mean | Geometric Coefficient of Variation | mL/min | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
|
|
|
| Primary | PK Parameter Vd | Vd = volume of distribution calculated after a single IV administration of RVP-001 | All subjects who received at least one dose of RVP-001 and had sufficient data to calculate at least one PK parameter | Posted | Geometric Mean | Geometric Coefficient of Variation | Liters | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
|
|
|
| Secondary | % RVP-001 Dose Excreted | mean % of RVP-001 excreted from urine from 0 -120 hours post dose | Posted | Mean | Standard Deviation | Mean % of dose recovered 0-120 hrs | pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose |
|
|
|
| 0 |
| 6 |
| 0 |
| 6 |
| 1 |
| 6 |
| EG001 | RVP-001: 4 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 4 mg Mn/kg administered via automated injection pump | 0 | 6 | 0 | 6 | 2 | 6 |
| EG002 | RVP-001: 7 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 7 mg Mn/kg administered via automated injection pump | 0 | 6 | 0 | 6 | 2 | 6 |
| EG003 | RVP-001: 12 mg Mn/kg | 6 subjects received RVP-001 in a single dose of 12 mg Mn/kg administered via automated injection pump | 0 | 6 | 0 | 6 | 0 | 6 |
| EG004 | Placebo Group | 8 subjects received placebo (saline) via automated injection pump | 0 | 8 | 0 | 8 | 1 | 8 |
| Dizziness | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA | Non-systematic Assessment |
|
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA | Non-systematic Assessment |
|
Not provided
Not provided
| D017670 |
| Sodium Compounds |