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Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate

NCT01523002 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56

Last updated 2023-12-14

Study results available
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Summary

The primary objective of the drug-drug interaction study is to evaluate any drug interaction between the CYP2D6 substrate metoprolol and pyronaridine-artesunate in healthy volunteers.

The primary objective of the pyronaridine-artesunate redosing study is to determine the safety of redosing a 3-day regimen of pyronaridine-artesunate following 60 or 90 days in healthy volunteers.

Conditions

Interventions

DRUG

Metoprolol and pyronaridine-artesunate

On Day 1, subjects will receive a single oral 100 mg dose of metoprolol tartrate. On Day 8 and Day 9, subjects will receive a once daily oral dose of pyronaridine-artesunate as follows: 55 - \< 65 kg: 3 tablets (180:60 mg pyronaridine:artesunate) ≥ 65 kg: 4 tablets (180:60 mg pyronaridine:artesunate) On Day 10, a 100 mg dose of metoprolol will be coadministered with pyronaridine-artesunate at the above dose. On Days 98 - 100, subjects will receive pyronaridine-artesunate once daily at the same dose described above. Followed by a 40 day follow-up period.

DRUG

pyronaridine-artesunate

On Days 1 to 3, subjects will receive 3 days of pyronaridine-artesunate as follows: 55 - \< 65 kg: 3 tablets (180:60 mg pyronaridine:artesunate) ≥ 65 kg: 4 tablets (180:60 mg pyronaridine:artesunate) On Days 61 to 63, subjects will be redosed with a 3 day course of pyronaridine-artesunate at the above dose. Followed by a 40 day follow-up period.

Sponsors & Collaborators

  • Shin Poong Pharmaceuticals

    collaborator INDUSTRY

  • Medicines for Malaria Venture

    lead OTHER

Principal Investigators

  • Rolf Pokorny, MD, MSc · Covance Research Unit AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-07-31
Completion
2012-10-31

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01523002 on ClinicalTrials.gov