Trial · NCT01523002

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

NCT01523002, Phase 1, Completed, Medicines for Malaria Venture; results first posted 2023-12-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate. Trials, record NCT01523002. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01523002

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate
NCT number: NCT01523002
Status: Completed
Phases: Phase 1
Enrollment: 56 participants, actual
Lead sponsor: Medicines for Malaria Venture
Conditions: Malaria
Interventions: Metoprolol and pyronaridine-artesunate, pyronaridine-artesunate
First posted: 2012-02-01
Last updated: 2023-12-14
Results first posted: 2023-12-14

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞	Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10	AUC0-t \& AUC0-∞ of Metoprolol \& α-hydroxymetoprolol for Period 1 (metoprolol alone) \& Period 2 (pyronaridine-artesunate with metoprolol) Abbreviations: AUC = area under the concentration-time curve; AUC0-t = AUC from Hour 0 to the last quantifiable concentration time (LQCT), where LQCT is the time at which the last sample with a quantifiable concentration was drawn; AUC0-∞ = AUC from Hour 0 to infinity
Primary	Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Tmax	Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10	tmax of Metoprolol \& α-hydroxymetoprolol for Period 1 (metoprolol alone) \& Period 2 (pyronaridine-artesunate with metoprolol) Abbreviations: tmax = time to maximum observed concentration.
Primary	Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: t1/2	Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10	t1/2 of Metoprolol \& α-hydroxymetoprolol for Period 1 (metoprolol alone) \& Period 2 (pyronaridine-artesunate with metoprolol) Abbreviations: t1/2 = apparent terminal phase half-life
Primary	Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Cmax	Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10	Cmax of Metoprolol \& α-hydroxymetoprolol for Period 1 (metoprolol alone) \& Period 2 (pyronaridine-artesunate with metoprolol) Abbreviations: Cmax = maximum peak observed concentration
Primary	World Health Organization (WHO) Treatment Emergent Adverse Events	140 days	To assess the safety of redosing a 3-day regimen of pyronaridine-artesunate. Grade 1: mild adverse event Grade 2: moderate adverse event Grade 3: severe and undesirable adverse event Grade 4: life threatening adverse event Grade 5: fatal adverse event resulting in death
Primary	Non-WHO Listed Treatment Emergent Adverse Events	140 days	To assess the safety of redosing a 3-day regimen of pyronaridine-artesunate

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞	Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10	26 participants analyzed for Period 1, 22 participants analyzed for Period 2 (22 participants reached D10 for data collection)	ng.h/ml	GEOMETRIC_MEAN
PRIMARY	Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Tmax	Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10	26 participants analyzed for Period 1, 22 participants analyzed for Period 2 (22 participants reached D10 for data collection)	hours	MEDIAN
PRIMARY	Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: t1/2	Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10	26 participants analyzed for Period 1, 22 participants analyzed for Period 2 (22 participants reached D10 for data collection)	hours	GEOMETRIC_MEAN
PRIMARY	Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Cmax	Plasma samples taken predose and following metoprolol dosing at 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 24 hours postdose on Days 1 & 10	26 participants analyzed for Period 1, 22 participants analyzed for Period 2 (22 participants reached D10 for data collection)	hours	GEOMETRIC_MEAN
PRIMARY	World Health Organization (WHO) Treatment Emergent Adverse Events	140 days		participants	NUMBER
PRIMARY	Non-WHO Listed Treatment Emergent Adverse Events	140 days		participants	NUMBER

Source ClinicalTrials.gov

Results by group36

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	Period 1 AUC0-t Metoprolol	685	Geometric Coefficient of Variation 91	ng.h/ml
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	Period 1 AUC0-∞ Metoprolol	746	Geometric Coefficient of Variation 89	ng.h/ml
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	Period 2 AUC0-t Metoprolol	895	Geometric Coefficient of Variation 77.0	ng.h/ml
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	Period 2 AUC0-∞ Metoprolol	958	Geometric Coefficient of Variation 77.3	ng.h/ml
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	Period 1 AUC0-t α-hydroxymetoprolol	707	Geometric Coefficient of Variation 51.6	ng.h/ml
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	Period 1 AUC0-∞ α-hydroxymetoprolol	804	Geometric Coefficient of Variation 41.9	ng.h/ml
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	Period 2 AUC0-t α-hydroxymetoprolol	601	Geometric Coefficient of Variation 72.2	ng.h/ml
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	Period 2 AUC0-∞ α-hydroxymetoprolol	739	Geometric Coefficient of Variation 49.5	ng.h/ml
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Tmax	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	Period 1 tmax Metoprolol	1.5	Full Range 0.75 to 3.00	hours
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Tmax	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	Period 2 tmax Metoprolol	1.00	Full Range 0.75 to 2.02	hours

1 to 10 of 36Source ClinicalTrials.gov

See all 36 results by group

Participant flow18

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Period 1	STARTED	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	26
Period 1	STARTED	Arm B: Pyronaridine-artesunate 60-day Redosing	30
Period 1	COMPLETED	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	24
Period 1	COMPLETED	Arm B: Pyronaridine-artesunate 60-day Redosing	19
Period 1	NOT COMPLETED	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	2
Period 1	NOT COMPLETED	Arm B: Pyronaridine-artesunate 60-day Redosing	11
Period 2	STARTED	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	24
Period 2	STARTED	Arm B: Pyronaridine-artesunate 60-day Redosing	19
Period 2	COMPLETED	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	18
Period 2	COMPLETED	Arm B: Pyronaridine-artesunate 60-day Redosing	13

1 to 10 of 18Source ClinicalTrials.gov

See all 18 participant flow

Adverse events124

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Diarrhoea	Gastrointestinal disorders	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	20	26	66
other	Diarrhoea	Gastrointestinal disorders	Arm B: Pyronaridine-artesunate 60-day Redosing	18	30	58
other	Nausea	Gastrointestinal disorders	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	12	26	18
other	Nausea	Gastrointestinal disorders	Arm B: Pyronaridine-artesunate 60-day Redosing	11	30	13
other	Vomiting	Gastrointestinal disorders	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	5	26	5
other	Vomiting	Gastrointestinal disorders	Arm B: Pyronaridine-artesunate 60-day Redosing	9	30	12
other	Abdominal pain	Gastrointestinal disorders	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	6	26	10
other	Abdominal pain	Gastrointestinal disorders	Arm B: Pyronaridine-artesunate 60-day Redosing	6	30	10
other	Abdominal pain discomfort	Gastrointestinal disorders	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	3	26	5
other	Abdominal pain discomfort	Gastrointestinal disorders	Arm B: Pyronaridine-artesunate 60-day Redosing	3	30	3

1 to 10 of 124Source ClinicalTrials.gov

See all 124 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	0	26
Total, all-cause mortality	Arm B: Pyronaridine-artesunate 60-day Redosing	0	30
Total, other adverse events	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	25	26
Total, other adverse events	Arm B: Pyronaridine-artesunate 60-day Redosing	29	30
Total, serious adverse events	Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing	0	26
Total, serious adverse events	Arm B: Pyronaridine-artesunate 60-day Redosing	2	30

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing vs Arm B: Pyronaridine-artesunate 60-day Redosing: deaths from any cause	Trial comparisons
Arm A: Metoprolol DDI and Pyronaridine-artesunate 90-day Redosing vs Arm B: Pyronaridine-artesunate 60-day Redosing: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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