Clinical trial NCT05413668: First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent
Official title: A Single Center, Double-Blinded, Phase 1a Randomized Study to Evaluate Safety and Pharmacokinetics of a New Manganese Based Magnetic Resonance Imaging (MRI) Contrast Agent, RVP-001, in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Reveal Pharmaceuticals Inc.
Sponsor class: INDUSTRY
Collaborators: name: National Cancer Institute (NCI)
name: Quotient Sciences
First posted: 2022-06-10
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male or female subjects
2. Healthy subjects aged 18 to 55 years inclusive
3. Suitable veins for phlebotomy, cannulation, or repeated venipuncture
4. Have a body mass index between 18 and 32 kg/m\^2 (inclusive); weigh at least 55 kg.
5. Appropriately completed written informed consent prior to any study specific procedures.

Exclusion Criteria:

1. Any clinically significant abnormality or abnormal laboratory test results found during medical screening
2. Vital sign abnormalities at screening or admission
3. History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease; neurological or psychiatric disorder, as judged by the investigator
4. Positive pregnancy test at screening or admission
5. History of alcohol abuse
6. History of drug abuse
7. Use of nicotine-containing products within 12 months of study start
8. Use of medication except topical products without significant systemic absorption
9. Known allergies to any component of RVP-001
10. 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.
11. Donation of plasma within 7 days prior to dosing; significant donation or loss of blood within 30 days prior to the first dosing.
12. Any reason which, in the opinion of the Principal Investigator, would prevent the subject from participating in the study.

Primary outcomes:
measure: Pharmacokinetic (PK) Parameter Cmax
timeFrame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
measure: PK Parameter Tmax
timeFrame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
measure: PK Parameter t1/2
timeFrame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
measure: PK Parameter Cl
timeFrame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
measure: PK Parameter Vd
timeFrame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
Secondary outcomes:
measure: % RVP-001 Dose Excreted
timeFrame: pre-dose, 2, 5, 10, 20, 30 min and 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 hours post-dose
Other outcomes:
Locations:
city: Miami
country: United States
facility: Quotient Sciences
state: Florida
Study officials:
affiliation: Reveal Pharmaceuticals
name: Srinivasan Mukundan, MD
role: STUDY_DIRECTOR
affiliation: Quotient Sciences
name: Jeffrey Levy, MD
role: PRINCIPAL_INVESTIGATOR
References: