ORFM-1B

About this trial

Last updated 9 years ago

Study ID

ORFM-1B

Status

Completed

Type

Interventional

Phase

Phase 1

Placebo

Accepting

22+ Years

All

Trial Timing

Ended 11 years ago

The purpose of this early feasibility study was to investigate the pharmacokinetics of MP-3180 administered in rising doses and to evaluate the use of the Optical Renal Function Monitor (ORFM), an investigational noninvasive fluorescence detection device.

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:

1. at least 50 kg (110 lbs) for men

2. at least 48 kg (106 lbs) for women

3. 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. 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.

3. 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.

4. Intolerance to venipuncture.

5. Participants who have received an investigational drug within 30 days prior to the initial dose of study medication.

6. History of drug and/or alcohol abuse within the past year, unless currently enrolled in an abstinence program.

7. History of allergy or hypersensitivity to MP-3180 or iohexol, or other related products, or any of the inactive ingredients.

8. History of skin sensitivity to adhesives (e.g. Band-Aids, surgical tape).

9. 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.

10. History of allergy or hypersensitivity to iodine containing contrast media or drugs.

11. Acute illness at the time of either the pre-study medical evaluation or dosing.

12. Social Habits:

1. Ingestion of any alcoholic, caffeine- or xanthine-containing food or beverage within the 48 hours prior to the initial dose of study medication.

2. Ingestion of any vitamins or herbal supplement within 7 days prior to the initial dose of study medication.

3. Any significant change in dietary or exercise habits within the 48 hours prior to the initial dose of study medication.

13. Medications: a. Use of any prescription or over-the-counter (OTC) medications within the 7 days prior to the initial dose of study medication.

14. Not within normal limits or clinically significant for lab testing; serum chemistries, hematology, urinalysis.

Pharmacokinetics of MP-3180 and Use of Noninvasive Fluorescence Detection Device in Healthy Volunteers