First in Human Study of RVP-001, a New Manganese Based MRI Contrast Agent

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05413668
• Other study ID #: RVL-101-22
• Secondary ID: R44CA268392
• Status: Completed
• Phase: Phase 1
• Start date: May 18, 2022
• Est. completion date: August 22, 2022

Study information

• Verified date: October 2023
• Source: Reveal Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 22, 2022
• Est. primary completion date: July 22, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• RVP-001
Intravenous administration of RVP-001
• Placebo
Intravenous administration of saline placebo

Locations

Country	Name	City	State
United States	Quotient Sciences	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Reveal Pharmaceuticals Inc.	National Cancer Institute (NCI), Quotient Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	% 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