Pharmacokinetics of MP-3180 in Healthy Volunteers

NCT ID: NCT02098174

Last Updated: 2016-09-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-01-31

Brief Summary

The purpose of this study was to investigate the pharmacokinetics of MP-3180 (1 µmol/kg) compared to the pharmacokinetics of iohexol (5 mL of a 300 mg iodine (I)/mL solution) in healthy adult participants. The secondary objective was to evaluate the safety and tolerability of MP-3180 in healthy adult participants.

Detailed Description

Single-dose pharmacokinetics were characterized in sixteen (16) healthy, adult male participants in this Phase 1, open-label study following the administration of a single, intravenous 1 µmol/kg dose over 2 minutes followed by 10 mL saline under fasting conditions. Iohexol (Omnipaque-300, 5 mL of a 300 mg I/mL solution) was also administered over 2 minutes followed by 10 mL of saline. The pharmacokinetics of MP-3180 and iohexol was assessed by statistical comparison of pharmacokinetic parameters derived from plasma concentration-time curves and urine recovery data.

Conditions

Glomerular Filtration Rate; Acute Kidney Injury

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Healthy participants

MP-3180 (1 µmol/kg or 0.372 mg/kg) was administered by IV injection (2.5 mL to 3.5 mL for participant weights of 70 kg to 91 kg) over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes. The iohexol comparator (Omnipaque 300, 5 mL) was then administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.

Group Type: EXPERIMENTAL

MP-3180

Intervention Type: DRUG

MP-3180 (1 µmol/kg or 0.372 mg/kg) (fluorescent tracer agent) was administered by IV injection (2.5 mL to 3.5 mL for participant weights of 70 kg to 91 kg) over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.

Iohexol comparator

Intervention Type: OTHER

Iohexol (Omnipaque 300, 5 mL) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.

Interventions

MP-3180

MP-3180 (1 µmol/kg or 0.372 mg/kg) (fluorescent tracer agent) was administered by IV injection (2.5 mL to 3.5 mL for participant weights of 70 kg to 91 kg) over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.

Intervention Type: DRUG

Iohexol comparator

Iohexol (Omnipaque 300, 5 mL) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 1. Age: 22 years of age or older
• 2. Sex: males and not of childbearing potential females
• 3. Capable of informed consent
• 4. Weight restrictions:

• a. at least 50 kg (110 lbs) for men
• b. at least 48 kg (106 lbs) for women
• c. All participants will have a Body Mass Index (BMI) less than or equal to 33 but greater than or equal to 19
• 5. All participants should be judged by the Principal Investigator or Medical Sub-Investigator physician as normal and healthy during a pre-study medical evaluation performed within 28 days of the initial dose of study medication

Exclusion Criteria

• 1. Institutionalized participants will not be used
• 2. Social habits:

• a. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.
• b. Ingestion of any vitamins or herbal supplement within 7 day prior to the initial dose of study medication.
• c. Any significant change in dietary or exercise habits within the 48 hours prior to the initial dose of study medication.
• d. History of drug and/or alcohol abuse within the past year, unless currently enrolled in an abstinence program.
• 3. Use of any prescription or over-the-counter (OTC) medications within the 7 days prior to the initial dose of study medication.
• 4. History of any significant cardiovascular disease, renal, pulmonary, hematologic, endocrine, immunologic, dermatologic, neurologic (including any history of seizure disorder), psychological, musculoskeletal disease or malignancies unless deemed not clinically significant by the Principal Investigator or Medical Sub-Investigator.
• 5. Acute illness at the time of either the pre-study medical evaluation or dosing.
• 6. Not within normal limits or clinically significant for lab testing
• 7. Any reason which, in the opinion of the Principal Investigator or Medical Sub-Investigator, would prevent the participant from safely participating in the study.
• 8. Donation or loss of blood or plasma: 50 mL to 499 mL within 30 days prior to the initial dose of the study medication; or more than 499 mL within 56 days prior to the initial dose of study medication.
• 9. Intolerance to venipuncture.
• 10. Participants who have received an investigational drug within 30 days prior to the initial dose of study medication.
• 11. History of allergy or hypersensitivity to MP-3180 or iohexol, or other related products, or any of the inactive ingredients.
• 12. Any food allergy, intolerance, restriction or special diet that, in the opinion of the Principal Investigator or Medical Sub-Investigator, could contraindicate the participant's participation in this study.
• 13. History of allergy or hypersensitivity to iodine containing contrast media or drugs.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

MediBeacon

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Dowling, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Maryland

Richard B. Dorshow, Ph.D.

Role: STUDY_DIRECTOR

MediBeacon, LLC

Locations

University of Maryland

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

ORFM-1A

Identifier Type: -

Identifier Source: org_study_id