Phase 1
Completed N=32
First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent
Healthy
Source: ClinicalTrials.gov NCT05413668 ↗
Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Oct 2023
Primary outcomePrimary: Pharmacokinetic (PK) Parameter Cmax — 264; 685; 992; 1960 nmol/mL
Summary
The objectives of this trial are:
1. To evaluate the safety and tolerability of single ascending doses of RVP-001 in healthy adult volunteers
2. To determine the pharmacokinetics and elimination of RVP-001 in healthy adult volunteers.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetic (PK) Parameter Cmax |
264; 685; 992; 1960 | — |
| PRIMARY PK Parameter Tmax |
0.065; 0.085; 0.084; 0.091 | — |
| PRIMARY PK Parameter t1/2 |
1.718; 1.765; 1.613; 1.839 | — |
| PRIMARY PK Parameter Cl |
122; 102; 122; 97.6 | — |
| PRIMARY PK Parameter Vd |
18.2; 15.6; 17.1; 15.5 | — |
| SECONDARY % RVP-001 Dose Excreted |
66.398; 73.623; 80.924; 74.90 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female subjects
- Healthy subjects aged 18 to 55 years inclusive
- Suitable veins for phlebotomy, cannulation, or repeated venipuncture
- Have a body mass index between 18 and 32 kg/m^2 (inclusive); weigh at least 55 kg.
- Appropriately completed written informed consent prior to any study specific procedures.
Exclusion Criteria
- Any clinically significant abnormality or abnormal laboratory test results found during medical screening
- Vital sign abnormalities at screening or admission
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease; neurological or psychiatric disorder, as judged by the investigator
- Positive pregnancy test at screening or admission
- History of alcohol abuse
- History of drug abuse
- Use of nicotine-containing products within 12 months of study start
- Use of medication except topical products without significant systemic absorption
- Known allergies to any component of RVP-001
- Subjects who have received any investigational product (IP) in a clinical research study within 5 IP half-lives or 30 days prior to first dose.
- Donation of plasma within 7 days prior to dosing; significant donation or loss of blood within 30 days prior to the first dosing.
- Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.
Data sourced from ClinicalTrials.gov (NCT05413668). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.