MalariaPhase 1NCT01523002
Drug Interaction Study of Pyronaridine-artesunate & Metoprolol, & Redosing Study of Pyronaridine-artesunate
A Phase 1 study testing Metoprolol and pyronaridine-artesunate and pyronaridine-artesunate in people with Malaria, run by Medicines for Malaria Venture at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Malaria
- What is being tested?
- Metoprolol and pyronaridine-artesunate and pyronaridine-artesunate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2012to Oct 2012
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female subjects between the ages of 18 and 55 years with a body weight between 50 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 a written informed consent form before undergoing any study related activities
- Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the investigator
- Strictly normal values of alanine aminotransferase, aspartate aminotransferase, and total bilirubin and normal or abnormal and clinically insignificant results of the other blood and urine laboratory parameters at screening.
- Female subjects of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who was post-menopausal (i.e. one year without menses) or who has undergone sterilization (via hysterectomy or bilateral tubal ligation)
- Female subjects of childbearing potential with a negative urine pregnancy test at screening confirmed at Day -1 by a serum pregnancy test and who agreed to one of the following methods:
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- Double barrier method of contraception for 2 weeks before first study drug administration and throughout the entire study follow up period
- Partner(s) who had undergone vasectomy and has been negative for sperm for at least 6 months
- 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 corrected QT interval greater or equal to 450 milliseconds), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including head trauma)
- Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins or metoprolol.
- Other contraindications to pyronaridine use
- Other contraindications to metoprolol use including second or third degree atrioventricular block, heart rate below 50 beats per minute, uncompensated heart failure or need for treatment with inotropic agents, clinically apparent hypotension, sinus bradycardia or sick sinus syndrome, peripheral arterial disease, pheochromocytoma, asthma, chronic obstructive pulmonary disease, depression and any other condition with in the opinion of the Investigator may be worsened by administration of metoprolol.
- Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab)
- Seropositive HIV antibody
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- Previous participation in any clinical study with pyronaridine:artesunate (Pyramax)
- Presence or recent history (last two years) of tobacco abuse (≥10 cigarettes/day)
- Known or suspected alcohol abuse or illicit drug use 10 years before the study start or positive findings on urine drug screen
- Intake of alcoholic beverages within 72 hours before study drug administration or caffeine-containing food or beverages, such as coffee, tea, chocolate, or cola, 48 hours before study drug administration
- Gilbert's disease
- Administration of any systemic medication or herbal product within 14 days before the first dose of study drug. If the investigator considers that the specific product would not interfere with the safety of the subject or the objectives of the study, topical treatments as well as vitamins and mineral supplements not containing other substances are allowed until 4 days before each dose. Ibuprofen at doses of at most 1200 mg per day for no more than 3 consecutive days or 6 non-consecutive days is allowed until 24h before the first dose of study drug.
- Plasma donation 3 months before the study start
- Blood donation of 500 mL or more 3 months before the study start
- Participation in any clinical study in last 3 months
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Covance Clinical Research Unit AG
Allschwil, Basel, 4123
About this study
Official title: Open-label, Drug Interaction Study of Pyronaridine-artesunate and Metoprolol in Healthy Volunteers and Pyronaridine-artesunate Redosing Study in Healthy Volunteers
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.
Read the detailed description
This was a phase I, open-label, randomised, 2-arm parallel group study in healthy subjects. The study population will include 44 healthy subjects (22 per treatment arm), comprising male and female adults (18-55 years) of any ethnic origin.
Subjects will be randomised to either Arm A or Arm B. Arm A will evaluate pyronaridine-artesunate interference on metoprolol pharmacokinetics (PK) and the effect of a 90-day (±7 days) redosing interval on the safety profile of pyronaridine-artesunate. Arm B will evaluate the effect of a 60-day (±7 days) redosing interval on the safety profile of pyronaridine-artesunate.
Screening will be performed in the 14-day period prior to the first dose. In Arm A, each subject will partake in 3 inpatients periods between: Days -1 to 2, Days 7 to 11, and Days 97 to 101, with dosing on Days 1, 8 to 10, and 98 to 100. In Arm B, each subject will partake in 2 inpatient periods: Days -1 to 4 and Days 60 to 64, with dosing on Days 1 to 3 and 61 to 63. Subjects will be considered to have completed the study at Day 140 (Arm A) or at Day 103 (Arm B).
Any adverse event ongoing at the time of study completion will be followed until resolution unless no further change is expected according to the investigator.
- Conditions
- Malaria
- Being tested
- Metoprolol and pyronaridine-artesunate, pyronaridine-artesunate
- Keywords
- pyronaridine artesunate (Pyramax), artemisinin based combination therapy (ACT), metoprolol, drug-drug interaction study, redosing study
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metoprolol and pyronaridine-artesunateDrug
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.
pyronaridine-artesunateDrug
Also called Pyramax
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: metoprolol and pyronaridine-artesunate 90-day redosing | Active comparator | Subjects will take 1 day of metoprolol followed by a 7 day wash out period, then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol, followed by a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period. Receives: Drug: Metoprolol and pyronaridine-artesunate |
| Arm B: pyronaridine-artesunate 60-day redosing | Active comparator | Subjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period. Receives: Drug: pyronaridine-artesunate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞
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
Measured: 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
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Tmax
tmax of Metoprolol \& α-hydroxymetoprolol for Period 1 (metoprolol alone) \& Period 2 (pyronaridine-artesunate with metoprolol)
Abbreviations: tmax = time to maximum observed concentration.
Measured: 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
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: t1/2
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
Measured: 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
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Cmax
Cmax of Metoprolol \& α-hydroxymetoprolol for Period 1 (metoprolol alone) \& Period 2 (pyronaridine-artesunate with metoprolol)
Abbreviations: Cmax = maximum peak observed concentration
Measured: 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
World Health Organization (WHO) Treatment Emergent Adverse Events
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
Measured: 140 days
Non-WHO Listed Treatment Emergent Adverse Events
To assess the safety of redosing a 3-day regimen of pyronaridine-artesunate
Measured: 140 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJul 2012
- Study completionOct 2012
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 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
- Rolf Pokorny, MD, MSc, Principal investigator, Covance Research Unit AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01523002
- Sponsor's protocol ID
- SP-C-014-11
- Status last verified
- Dec 2023
- First submitted
- 27 Jan 2012
- Last updated
- 14 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Drug Interaction Study of Pyronaridine-artesunate and Metoprolol in Healthy Volunteers and Pyronaridine-artesunate Redosing Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01523002
- Acronym / sponsor ID
- SP-C-014-11
- Conditions
- Malaria
- Keywords
- pyronaridine artesunate (Pyramax), artemisinin based combination therapy (ACT), metoprolol, drug-drug interaction study, redosing study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Medicines for Malaria VentureUniversity, hospital or other
- Collaborators
- Shin Poong Pharmaceuticals
- Study start
- Jan 2012
- Primary completion
- Jul 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 1 Feb 2012 (estimated)
- Results
- Posted 14 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a phase I, open-label, randomised, 2-arm parallel group study in healthy subjects. The study population will include 44 healthy subjects (22 per treatment arm), comprising male and female adults (18-55 years) of any ethnic origin.
Subjects will be randomised to either Arm A or Arm B. Arm A will evaluate pyronaridine-artesunate interference on metoprolol pharmacokinetics (PK) and the effect of a 90-day (±7 days) redosing interval on the safety profile of pyronaridine-artesunate. Arm B will evaluate the effect of a 60-day (±7 days) redosing interval on the safety profile of pyronaridine-artesunate.
Screening will be performed in the 14-day period prior to the first dose. In Arm A, each subject will partake in 3 inpatients periods between: Days -1 to 2, Days 7 to 11, and Days 97 to 101, with dosing on Days 1, 8 to 10, and 98 to 100. In Arm B, each subject will partake in 2 inpatient periods: Days -1 to 4 and Days 60 to 64, with dosing on Days 1 to 3 and 61 to 63. Subjects will be considered to have completed the study at Day 140 (Arm A) or at Day 103 (Arm B).
Any adverse event ongoing at the time of study completion will be followed until resolution unless no further change is expected according to the investigator.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: metoprolol and pyronaridine-artesunate 90-day redosing | Active comparator | Drug: Metoprolol and pyronaridine-artesunateSubjects will take 1 day of metoprolol followed by a 7 day wash out period, then 2 days of pyronaridine-artesunate followed by 1 day of pyronaridine-artesunate + metoprolol, followed by a 87 day follow-up period. Subjects will then receive pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period. |
| Arm B: pyronaridine-artesunate 60-day redosing | Active comparator | Drug: pyronaridine-artesunateSubjects will take pyronaridine-artesunate once daily for 3 days, followed by a 57 day follow-up period. Subjects will then take pyronaridine-artesunate once daily for 3 days followed by a 40 day follow-up period. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male or female subjects between the ages of 18 and 55 years with a body weight between 50 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 a written informed consent form before undergoing any study related activities
- Medically normal subjects with no significant abnormal findings at the screening physical examination as evaluated by the investigator
- Strictly normal values of alanine aminotransferase, aspartate aminotransferase, and total bilirubin and normal or abnormal and clinically insignificant results of the other blood and urine laboratory parameters at screening.
- Female subjects of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who was post-menopausal (i.e. one year without menses) or who has undergone sterilization (via hysterectomy or bilateral tubal ligation)
Key exclusion criteria (15 listed)
- Known history or evidence of clinically significant disorders such as cardiovascular (including arrhythmia, acute corrected QT interval greater or equal to 450 milliseconds), respiratory (including active tuberculosis), hepatic, renal, gastrointestinal, immunological (including active HIV-AIDS), neurological (including auditory), endocrine, infectious, malignancy, psychiatric or other abnormality (including head trauma)
- Known history of hypersensitivity, allergic or adverse reactions to pyronaridine or artesunate or other artemisinins or metoprolol.
- Other contraindications to pyronaridine use
- Other contraindications to metoprolol use including second or third degree atrioventricular block, heart rate below 50 beats per minute, uncompensated heart failure or need for treatment with inotropic agents, clinically apparent hypotension, sinus bradycardia or sick sinus syndrome, peripheral arterial disease, pheochromocytoma, asthma, chronic obstructive pulmonary disease, depression and any other condition with in the opinion of the Investigator may be worsened by administration of metoprolol.
- Known active Hepatitis A IgM (HAV-IgM), Hepatitis B surface antigen (HBsAg) or Hepatitis C antibody (HCV Ab)
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 |
|---|---|---|
| Metoprolol and pyronaridine-artesunateOn 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 | Arm A: metoprolol and pyronaridine-artesunate 90-day redosing |
| pyronaridine-artesunateAlso: PyramaxOn 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. | Drug | Arm B: pyronaridine-artesunate 60-day redosing |
Primary outcome
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞
Time frame: 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
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Tmax
Time frame: 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.
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: t1/2
Time frame: 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
Arm A Pharmacokinetics Parameters of Metoprolol & α-hydroxymetoprolol: Cmax
Time frame: 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
World Health Organization (WHO) Treatment Emergent Adverse Events
Time frame: 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
Non-WHO Listed Treatment Emergent Adverse Events
Time frame: 140 days
To assess the safety of redosing a 3-day regimen of pyronaridine-artesunate
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2023.
- 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.
Rolf Pokorny, MD, MSc principal investigator
Covance Research Unit AG
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 Metoprolol and pyronaridine-artesunate and pyronaridine-artesunate 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 9 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 14 Dec 2023. 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 14 Dec 2023). 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?
Arm A Pharmacokinetic Parameters of Metoprolol & α-hydroxymetoprolol: Area Under Curve (AUC)0-t, AUC0-∞ (time frame: 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). The study lists 6 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 14 Dec 2023.