MalariaPhase 1NCT01383109
Human Mass Balance Study of Pyronaridine
A Phase 1 study testing 14C-labeled Pyronaridine in people with Malaria, run by Medicines for Malaria Venture at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- 14C-labeled Pyronaridine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jun 2011to Dec 2011
- Phase
- Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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)
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- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Covance Clinical Research Unit AG
Allschwil, Basel, 4123
About this study
Official title: A Human Mass Balance Study of Pyronaridine Using Accelerator Mass Spectrometry
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.
Read the detailed description
This is a monocenter, open-label, non-placebo-controlled, single-group, single-dose study. Six male subjects will receive a single dose of Pyronaridine 720 mg orally administered together with 14C-Pyronaridine (approx. 100 µg, 800 nCi (29600 Bq)).
Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) and adverse events will be monitored throughout the study. Subjects will come to the clinic the evening before the dosing of Pyronaridine. After the drug intake at day 1, subjects will have regular in-house periods for specimen collection up to 87 days after the drug administration. Blood, feces and urine will be collected during the hospitalisation periods. Samples will be analyzed for radioactivity by Accelerator Mass Spectrometry (AMS).
- Conditions
- Malaria
- Being tested
- 14C-labeled Pyronaridine
- Keywords
- Mass Balance, Accelerated Mass Spectrometry (AMS), microdose, Focus of the study: ADME
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-labeled PyronaridineDrug
Single dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi).
| Study group | Role | What they receive |
|---|---|---|
| Pyronaridine | Experimental | All subjects will receive a single dose of Pyronaridine Receives: Drug: 14C-labeled Pyronaridine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2064 hours
Secondary outcomes (3)
Total Radioactivity in Blood: AUC0-t, AUC0-∞
Pharmacokinetic Parameters:
AUC0-t: area under the plasma concentration-time curve from Hour 0 through the last quantifiable concentration time (LQCT), where LQCT is the time at which the last sample with a quantifiable concentration was collected AUC0-∞: area under the plasma concentration-time curve from Hour 0 to infinity
PK sampling performed at predose, 0.5, 1, 2, 4, 8, 12 and 24 hours, and 2, 4, 6, 7, 14, 21, 28, 35 and 42 days post-dose
Measured: 42 days
Total Radioactivity in Blood: Cmax
Pharmacokinetic Parameters:
Cmax: maximum observed peak observed concentration
PK sampling performed at predose, 0.5, 1, 2, 4, 8, 12 and 24 hours, and 2, 4, 6, 7, 14, 21, 28, 35 and 42 days post-dose
Measured: 42 days
Total Radioactivity in Blood: Half-life, Tmax
Pharmacokinetic Parameters:
Half-life: computed as ln (2) / Kel Tmax: time to maximum concentration
PK sampling performed at predose, 0.5, 1, 2, 4, 8, 12 and 24 hours, and 2, 4, 6, 7, 14, 21, 28, 35 and 42 days post-dose
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionSep 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for MalariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medicines for Malaria Venture
- Sponsor type
- University, hospital or other
- Collaborators
- Shin Poong Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Isabelle Borghini Fuhrer, PhD, Study director, Medicines for Malaria Venture
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01383109
- Sponsor's protocol ID
- SP-C-012-11
- Status last verified
- Nov 2021
- First submitted
- 22 Jun 2011
- Last updated
- 26 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Human Mass Balance Study of Pyronaridine Using Accelerator Mass Spectrometry
- ClinicalTrials.gov ID
- NCT01383109
- Acronym / sponsor ID
- SP-C-012-11
- Conditions
- Malaria
- Keywords
- Mass Balance, Accelerated Mass Spectrometry (AMS), microdose, Focus of the study: ADME
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Shin Poong Pharmaceuticals
- Study start
- Jun 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 28 Jun 2011 (estimated)
- Results
- Posted 26 Jan 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a monocenter, open-label, non-placebo-controlled, single-group, single-dose study. Six male subjects will receive a single dose of Pyronaridine 720 mg orally administered together with 14C-Pyronaridine (approx. 100 µg, 800 nCi (29600 Bq)).
Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) and adverse events will be monitored throughout the study. Subjects will come to the clinic the evening before the dosing of Pyronaridine. After the drug intake at day 1, subjects will have regular in-house periods for specimen collection up to 87 days after the drug administration. Blood, feces and urine will be collected during the hospitalisation periods. Samples will be analyzed for radioactivity by Accelerator Mass Spectrometry (AMS).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pyronaridine | Experimental | Drug: 14C-labeled PyronaridineAll subjects will receive a single dose of Pyronaridine |
Who may qualify
- Ages
- 40 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- 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:
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14C-labeled PyronaridineSingle dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi). | Drug | Pyronaridine |
Primary outcome
Analysis of 14C-Pyronaridine Total Radioactivity in Urine
Time frame: 2064 hours
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
Analysis of 14C-Pyronaridine Total Radioactivity in Feces
Time frame: 2064 hours
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
3 secondary outcomes
Total Radioactivity in Blood: AUC0-t, AUC0-∞
Time frame: 42 days
Total Radioactivity in Blood: Cmax
Time frame: 42 days
Total Radioactivity in Blood: Half-life, Tmax
Time frame: 42 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Borghini Fuhrer, PhD study director
Medicines for Malaria Venture
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 14C-labeled Pyronaridine in people with Malaria, run by Medicines for Malaria Venture at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of 14C-Pyronaridine Total Radioactivity in Urine (time frame: 2064 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2022.