- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04250363
Chemoprophylactic Activity of M5717 in PfSPZ Challenge Model
November 7, 2023 updated by: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
A Phase Ib, Randomized, Double-Blind, Placebo Controlled, Sequential Study of Single Oral Doses of M5717 to Explore the Chemoprophylactic Activity of M5717 in a Controlled PISPZ Challenge Model in Healthy Participants
The main purpose of this study was to assess the chemoprophylactic activity and dose-exposure-response relationship of single oral dose of M5717 administered after direct intravenous inoculation (DVI) of Plasmodium falciparum sporozoite (PfSPZ) challenge in healthy participants.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Leiden, Netherlands
- Leiden University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Participants who are overtly healthy as determined by medical evaluation, including no clinically significant abnormality identified on physical examination or laboratory evaluation and no active clinically significant disorder, condition, infection or disease that would pose a risk to participant safety or interfere with the study evaluation, procedures or completion
- Participants who have a body weight within 50 to 100 kilograms (kg) and body mass index within the range 19.0 to 29.9 kilograms per meter square (kg/m2) (inclusive)
- Male participants, during the study intervention period and for at least 120 days after the day of the study intervention dose (covering a full sperm cycle of 90 days starting after 5 half lives of last dose of study intervention: - refrain from donating sperm plus, either - abstain from intercourse with a woman of childbearing potential (WOCBP) or - use a male condom, when having sexual intercourse with a WOCBP, who is not currently pregnant, and advise her to use a highly effective contraceptive method with a failure rate of less than (<) 1 percent (%) per year, since a condom may break or leak
- Female participants who are: - not a WOCBP; - at least 1 year post-menopausal (amenorrhea greater than or equal to [>=] 12 months and follicle-stimulating hormone [FSH] >= 40 milli-international units per milliliter [mIU/mL]) at screening; - surgically sterile (bilateral oophorectomy, hysterectomy or bilateral salpingectomy; tubal ligation alone is not sufficient)
- Participants who are capable of giving signed informed consent, which includes compliance with the requirements (including mandatory intake of rescue medication to participants who have been administered the investigational Plasmodium falciparum sporozoite challenge) and restrictions listed in the informed consent form (ICF) and this protocol
- Other protocol defined inclusion criteria could apply
Exclusion Criteria:
- Participants with 12-Lead electrocardiogram (ECG) outside normal range (QTcF greater than [>] 450 milli seconds [ms], pulse rate [PR] > 215 ms, or QRS > 120 ms) and deemed clinically relevant by the Investigator
- Supine systolic blood pressure > 140 or < 90 millimeter of mercury (mmHg), diastolic blood pressure > 90 or < 50 mmHg, and pulse rate > 90 or < 50 beats per minute (min) at screening and at admission on Day -1 (any abnormal blood pressure or pulse rate results may be repeated once and if the repeat result is within the normal range, it is not considered to have met the exclusion criterion)
- Seropositive for human immunodeficiency virus (HIV) I and II antibody or antigen), hepatitis B virus (HBV; hepatitis B surface antigen [HBsAg]), or hepatitis C virus (HCV; antibody) tests
- Liver function tests above the upper limit of normal (ULN) (> 3 x ULN) the day before DVI / study intervention administration (Day -1)
- History or presence of diagnosed food or known drug allergies (including but not limited to allergy to any of the antimalarial rescue medications to be used in the study), or history of anaphylaxis or other severe allergic reactions
- Participant with a whole blood donation or loss of > 450 mL within 60 days before administration of study drug or unwilling to defer blood donations for 6 months
- Other protocol defined exclusion criteria could apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Early liver stage: Pooled Placebo
Participants received single dose of placebo matched to M5717 capsule on Day 1 after 2 hours of Plasmodium falciparum Sporozoite (PfSPZ) (3200 sporozoites per injection) intravenous (IV) inoculation administration on Day 1.
|
Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
Participants received single oral dose of placebo matched to M5717 capsule on Day 1.
|
Experimental: Early liver stage: 30 mg M5717
Participants received single dose of M5717 30 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
|
Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
Participants received 30 mg single oral dose of M5717 capsule on Day 1.
|
Experimental: Early liver stage: 60 mg M5717
Participants received single dose of M5717 60 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
|
Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
Participants received 60 mg single oral dose of M5717 capsule on Day 1.
Participants received 60 mg single oral dose of M5717 capsule on Day 5.
|
Experimental: Early liver stage: 80 mg M5717
Participants received single dose of M5717 80 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
|
Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
Participants received 80 mg single oral dose of M5717 capsule on Day 1.
|
Experimental: Early liver stage: 100 mg M5717
Participants received single dose of M5717 100 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
|
Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
Participants received 100 mg single oral dose of M5717 capsule on Day 1.
Participants received 100 mg single oral dose of M5717 capsule on Day 5.
|
Experimental: Early liver stage: 200 mg M5717
Participants received single dose of M5717 200 mg capsule on Day 1 after 2 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
|
Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
Participants received 200 mg single oral dose of M5717 capsule on Day 1.
Participants received 200 mg single oral dose of M5717 capsule on Day 5.
|
Experimental: Late liver stage: Pooled Placebo
Participants received single dose of placebo matched to M5717 capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
|
Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
Participants received single oral dose of placebo matched to M5717 capsule on Day 5.
|
Experimental: Late liver stage: 60 mg M5717
Participants received single dose of M5717 60 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
|
Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
Participants received 60 mg single oral dose of M5717 capsule on Day 1.
Participants received 60 mg single oral dose of M5717 capsule on Day 5.
|
Experimental: Late liver stage: 100 mg M5717
Participants received single dose of M5717 100 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
|
Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
Participants received 100 mg single oral dose of M5717 capsule on Day 1.
Participants received 100 mg single oral dose of M5717 capsule on Day 5.
|
Experimental: Late liver stage: 200 mg M5717
Participants received single dose of M5717 200 mg capsule on Day 5 after 96 hours of PfSPZ (3200 sporozoites per injection) IV inoculation administration on Day 1.
|
Participants received 3200 units of Plasmodium falciparum sporozoites by DVI on Day 1.
Participants received 200 mg single oral dose of M5717 capsule on Day 1.
Participants received 200 mg single oral dose of M5717 capsule on Day 5.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early Liver Stage: Number of Participants Over Time With Positive Parasitemia
Time Frame: Early Liver Stage: From Day 1 up to Day 28
|
Number of participants with positive parasitemia defined as first positive quantitative polymerase chain reaction (qPCR) outcome equal or greater than 100 asexual parasites per milliliter (mL) of blood within 28 days of PfSPZ challenge.
|
Early Liver Stage: From Day 1 up to Day 28
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Late Liver Stage: Number of Participants Over Time With Positive Parasitemia
Time Frame: Late Liver Stage: From Day 5 up to Day 32
|
Number of participants with positive parasitemia defined as first positive quantitative polymerase chain reaction (qPCR) outcome equal or greater than 100 asexual parasites per milliliter (mL) of blood within 28 days of PfSPZ challenge.
|
Late Liver Stage: From Day 5 up to Day 32
|
Early Liver Stage: Time to First Positive Parasitemia Based on Quantitative Polymerase Chain Reaction (qPCR)
Time Frame: Early Liver Stage: From Day 1 up to Day 28
|
Time to first positive parasitemia was defined as the time (i.e., number of days) from the PfSPZ DVI (i.e., date of DVI PfSPZ) to the first qPCR outcome greater than or equal to (>=) 100 asexual parasites per milliliter (mL) of blood.
|
Early Liver Stage: From Day 1 up to Day 28
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Late Liver Stage: Time to First Positive Parasitemia Based on Quantitative Polymerase Chain Reaction (qPCR)
Time Frame: Late Liver Stage: From Day 5 up to Day 32
|
Time to first positive parasitemia was defined as the time (i.e., number of days) from the PfSPZ DVI (i.e., date of DVI PfSPZ) to the first qPCR outcome greater than or equal to (>=) 100 asexual parasites per milliliter (mL) of blood.
|
Late Liver Stage: From Day 5 up to Day 32
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Early Liver Stage: Number of Participants With Documented Blood Stage Parasite Growth
Time Frame: Early Liver Stage: From Day 1 up to Day 28
|
Documented blood stage parasite growth was defined as an increase of qPCR measured asexual parasites per mL compared to the first parasitemia measurement, within 28 days of PfSPZ DVI.
|
Early Liver Stage: From Day 1 up to Day 28
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Late Liver Stage: Number of Participants With Documented Blood Stage Parasite Growth
Time Frame: Late Liver Stage: From Day 5 up to Day 32
|
Documented blood stage parasite growth was defined as an increase of qPCR measured asexual parasites per mL compared to the first parasitemia measurement, within 28 days of PfSPZ DVI.
|
Late Liver Stage: From Day 5 up to Day 32
|
Early Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score
Time Frame: Early Liver Stage: At Day 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26 and 28
|
The malaria clinical score consisted of 14 signs/symptoms frequently associated with malaria and graded using a 4-point scale (absent: 0; mild: 1; moderate: 2; severe: 3) and summed to generate a total malaria clinical score (maximum score possible is 42): headache, myalgia (muscle ache), arthralgia (joint ache), fatigue/lethargy, malaise (general discomfort/uneasiness), chills/shivering/rigors, sweating/hot spells, anorexia, nausea, vomiting, abdominal discomfort, fever, tachycardia and hypotension.
The minimum score was 0 (no symptoms) and the maximum score was 42 (maximum symptoms).
Total scores are reported here.
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Early Liver Stage: At Day 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 22, 24, 26 and 28
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Late Liver Stage: Clinical Symptoms of Malaria Assessed Using Malaria Clinical Score
Time Frame: Late Liver Stage: At Day 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 26, 28, 30 and 32
|
The malaria clinical score consisted of 14 signs/symptoms frequently associated with malaria and graded using a 4-point scale (absent: 0; mild: 1; moderate: 2; severe: 3) and summed to generate a total malaria clinical score (maximum score possible is 42): headache, myalgia (muscle ache), arthralgia (joint ache), fatigue/lethargy, malaise (general discomfort/uneasiness), chills/shivering/rigors, sweating/hot spells, anorexia, nausea, vomiting, abdominal discomfort, fever, tachycardia and hypotension.
The minimum score was 0 (no symptoms) and the maximum score was 42 (maximum symptoms).
Total scores are reported here.
|
Late Liver Stage: At Day 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 26, 28, 30 and 32
|
Dose Exposure Response Relationship of M5717 Assessed by Logistic Regression Model
Time Frame: From Day 5 up to Day 32
|
Exposure efficacy relationship was analyzed using logistic regression model.
Different exposure matrices (AUC0-24, AUC0-168, AUC0-inf, C24 and C168) were analyzed using logistic regression model.
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From Day 5 up to Day 32
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs and Treatment-related TEAEs
Time Frame: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
|
An adverse event (AE) was defined as any untoward medical occurrence in a participant administered with study drug which does not necessarily had a causal relationship with the treatment.
An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of a medicinal product, whether or not considered related to the medicinal product.
A serious adverse event (SAE) was an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important.
TEAE was defined as AEs starting or worsening after the first intake of the study drug.
TEAEs included both serious TEAEs and non-serious TEAEs.
Treatment-related TEAEs: reasonably related to study intervention.
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Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
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Number of Participants With Treatment Emergent Adverse Events (TEAEs) Based on Severity
Time Frame: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
|
Severity of adverse events (AE) were assessed by the investigator per the Qualitative Toxicity Scale.
Grade 1= Mild, Grade 2=Moderate, Grade 3=Severe.
The number of participants that experienced at least one solicited local TEAE were summarized by grade.
The term TEAE is defined as AEs starting or worsening after the first intake of the study drug.
TEAEs include both Serious TEAEs and non-serious TEAEs.
Number of participants with Grade=1, Grade=2 and 3 were reported.
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Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
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Number of Participants With Clinically Significant Change From Baseline in Laboratory Values
Time Frame: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
|
Laboratory assessments included hematology, biochemistry, urinalysis, and coagulation.
Number of participants with clinically significant changes from baseline in laboratory values which were deemed clinically significant by the investigator were reported.
|
Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
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Number of Participants With Clinically Significant Change From Baseline in Vital Signs
Time Frame: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
|
Vital signs included oral body temperature, height, weight, systolic blood pressure, diastolic blood pressure, and pulse rate.
Number of participants with clinically significant changes from baseline in Vital signs which were deemed clinically significant by the investigator were reported.
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Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
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Number of Participants With Clinically Significant Change From Baseline in 12-lead Electrocardiogram (ECG) Findings
Time Frame: Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
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Single 12-lead ECG was obtained as outlined using an ECG machine that automatically calculates the heart rate and measures PR, QRS, and QT intervals.
Number of participants with clinically significant changes from baseline in ECG which were deemed clinically significant by the investigator were reported.
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Early Liver Stage: From Day 1 up to Day 33; Late Liver Stage: From Day 1 up to Day 36
|
Area Under the Blood Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-inf) of M5717
Time Frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
|
AUC0-inf was calculated by combining AUC0-t and AUCextra.
AUC extra represents an extrapolated value obtained by Clast/ λz, where Clast is the calculated blood concentration at the last sampling time point at which the measured blood concentration is at or above the Lower Limit of quantification (LLQ) and λz is the apparent terminal rate constant determined by log-linear regression analysis of the measured blood concentrations of the terminal log-linear phase.
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Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
|
Area Under the Blood Concentration-Time Curve From Time Zero to the Last Sampling Time (AUC 0-tlast) of M5717
Time Frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
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Area under the blood concentration vs time curve from time zero to the last sampling time t at which the concentration was at or above the lower limit of quantification (LLQ).
AUC0-t was to be calculated according to the mixed log-linear trapezoidal rule.
|
Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
|
Area Under the Blood Concentration-Time Curve From Time Zero to 24 Hours Post-dose (AUC 0-24) of M5717
Time Frame: Pre-dose, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose
|
AUC from time zero to 24 hours post dose, calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval.
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Pre-dose, 0.5, 1, 2, 3, 6, 12 and 24 hours post-dose
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Area Under the Blood Concentration-Time Curve From Time Zero to 168 Hours Post-dose (AUC 0-168) of M5717
Time Frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120 and 168 hours post-dose
|
AUC from time zero to 168 hours post dose.
Calculated using the mixed log linear trapezoidal rule (linear up, log down) using the nominal dosing interval.
|
Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120 and 168 hours post-dose
|
Maximum Observed Blood Concentration (Cmax) of M5717
Time Frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
|
Cmax was obtained directly from the concentration versus time curve.
|
Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
|
Blood Concentration at 24 Hours (C24) of M5717
Time Frame: At 24 hours post-dose
|
Blood samples for PK analysis of C24 of M5717 was reported.
|
At 24 hours post-dose
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Blood Concentration at 168 Hours (C168) of M5717
Time Frame: At 168 hours post-dose
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C168 is the calculated blood concentration at 168 hours post-dose at which the measured blood concentration is at or above the Lower Limit of quantification (LLQ).
|
At 168 hours post-dose
|
Time to Reach Maximum Blood Concentration (Tmax) of M5717
Time Frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
|
Time to reach the maximum blood concentration (Tmax) was obtained directly from the concentration versus time curve.
|
Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
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Apparent Terminal Half-life (t1/2) of M5717
Time Frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
|
Terminal half-life is the time measured for the concentration to decrease by one half.
Terminal half-life calculated by natural log 2 divided by lambda z.
|
Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
|
Elimination Rate Constant (Lambda z) of M5717
Time Frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
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Elimination rate constant determined from the terminal slope of the log-transformed concentration curve using linear regression on terminal data points of the curve.
|
Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
|
Apparent Total Body Clearance From Blood (CL/f) of M5717
Time Frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
|
Clearance of a drug was a measure of the rate at which a drug is metabolized or eliminated by normal biological processes.
Apparent body clearance of the drug from blood, CL= Dose/AUC0-inf
|
Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
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Apparent Volume of Distribution (Vz/F) During the Terminal Phase of M5717
Time Frame: Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
|
The Vz/f was defined as the theoretical volume in which the total amount of required to uniformly distribute to produce the desired plasma concentration.
Apparent volume of distribution after oral dose (Vz/F) was influenced by the fraction absorbed.
The Vz/f was calculated by dividing the dose with area under the concentration time curve from time zero to infinity multiplied with terminal elimination rate constant Lambda(z).
Vz/f=Dose/AUC(0-inf) multiply Lambda(z).
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Pre-dose, 0.5, 1, 2, 3, 6, 12, 24, 120, 168, 192, 600, and 768 hours post-dose
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Medical Responsible, Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 17, 2020
Primary Completion (Actual)
August 18, 2021
Study Completion (Actual)
August 18, 2021
Study Registration Dates
First Submitted
January 29, 2020
First Submitted That Met QC Criteria
January 29, 2020
First Posted (Actual)
January 31, 2020
Study Record Updates
Last Update Posted (Actual)
May 1, 2024
Last Update Submitted That Met QC Criteria
November 7, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- MS201618_0003
- 2019-003414-14 (EudraCT Number)
- 203481/Z/16/Z (Other Grant/Funding Number: Wellcome Trust)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We are committed to enhancing public health through responsible sharing of clinical trial data.
Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research.
Further information on how to request data can be found on our website bit.ly/IPD21
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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