Human Mass Balance Study of Pyronaridine

NCT01383109 | Completed Phase 1 Results DMC

• 1 other identifier: SP-C-012-11
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The combination of pyronaridine and artesunate is an antimalarial therapy in development. This mass balance study is intended to determine the rate and extent of excretion of total radioactivity in urine and feces following administration of a single oral micro-dose of 14C-pyronaridine in humans.

Conditions

Malaria

Keywords

Mass Balance; Accelerated Mass Spectrometry (AMS); microdose; Focus of the study: ADME

Outcome Measures

Primary Outcomes (2)

• Analysis of 14C-Pyronaridine Total Radioactivity in Urine

  Radioactivity recovery in urine as a percent of the administered dose. Continuous collection of samples was performed through 168 hours post-dose, with intermittent 48 hour collections occurring thereafter

  2064 hours

• Analysis of 14C-Pyronaridine Total Radioactivity in Feces

  Radioactivity recovery in feces as a percent of the administered dose. Continuous collection of samples was performed through 168 hours post-dose, with intermittent 48 hour collections occurring thereafter

  2064 hours

Secondary Outcomes (3)

• Total Radioactivity in Blood: AUC0-t, AUC0-∞

  42 days

• Total Radioactivity in Blood: Cmax

  42 days

• Total Radioactivity in Blood: Half-life, Tmax

  42 days

Study Arms (1)

Pyronaridine

EXPERIMENTAL

All subjects will receive a single dose of Pyronaridine

Drug: 14C-labeled Pyronaridine

Interventions

14C-labeled Pyronaridine DRUG

Single dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi).

Pyronaridine

Eligibility Criteria

• Age: 40 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male subjects between the ages of 40 and 55 years with a body weight between 60 and 90 kg and a body mass index calculated using Quetelet's Index - weight (kg)/height2 (m2) between 18.5 - 30.0
• Signed and dated written informed consent form (ICF) before undergoing any study related activities, including discontinuation of any prohibited medications
• Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the investigator
• Strictly normal values of ALT, AST and bilirubin and normal or abnormal and clinically insignificant results (if agreed by the Investigator and the Sponsor on a case by case evaluation) of the other blood and urine laboratory parameters at screening
• All sexually active male subjects and their partners are willing to undergo contraception as follows:
• All male subjects, including those who are sterilised (i.e., vasectomy), should use a condom. Their female partner must also use at least 1 of the medically acceptable forms of contraceptives listed below. Male subjects must not donate sperm or have unprotected sex during the study and until 87 days after taking the dose of investigational product.
• Medically acceptable contraceptives for this study are:
• Condoms in addition to:
• Intrauterine devices
• Hormonal contraceptives (oral, depot, patch, injectable, or vaginal ring)
• Diaphragms with spermicidal cream or gel
• Cervical cap with spermicidal cream or gel
• Spermicidal foam
• The ability to understand the requirements of the study and willingness to comply with all study procedures

You may not qualify if:

• Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, acute QTc interval greater or equal to 450 mseconds), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other clinical abnormality
• Known history of hypersensitivity, allergic or adverse reactions to Pyronaridine
• Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab)
• Seropositive HIV antibody
• Previous participation in any clinical study with Pyramax
• Presence or recent history (last two years) of tobacco abuse (≥10 cigarettes/day)
• Known or suspected alcohol abuse or illicit drug use in the last 10 years before the study start or positive findings on urine drug screen
• Intake of grapefruit and grapefruit juice alcoholic beverages or caffeine-containing food or beverages, such as coffee, tea, chocolate, or cola, 48 hours before study drug administration
• Use of over-the-counter (OTC) medications, including vitamins, analgesics, or antacids, 1 week before the study start
• Use of prescription medications 14 days before the study start or required chronic use of any prescription medication
• Use of enzyme-altering agents (e.g., barbiturates, phenothiazines, cimetidine, etc.) within 30 days or 5 half lives, whichever the longer, before the study start
• Plasma donation 1 month before the study start
• Blood donation of 450 mL or more in the last 3 months before the study start
• Participation in other clinical trials during the previous month in which an investigational drug or a commercially available drug was tested
• Exposure to artificial ionizing radiation in the last 12 months (e.g., x-ray investigation, isotope studies)

Sponsors & Collaborators

• Medicines for Malaria Venture: lead
• Shin Poong Pharmaceuticals: collaborator

Study Sites (1)

Covance Clinical Research Unit AG

Allschwil, Basel, 4123, Switzerland

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Results Point of Contact

• Title: Jansik Shin
• Organization: Shin Poong Pharmaceutical Co., Ltd.

jsshin@shinpoong.co.kr

+82-2-2189-3468

Study Officials

• Isabelle Borghini Fuhrer, PhD

  Medicines for Malaria Venture

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 28, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: January 26, 2022
• Results First Posted: January 26, 2022

Record last verified: 2021-11

Locations

CH (1)