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Safety, Tolerability and Pharmacokinetics of BIIB118 (PF-05251749)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02443740
Recruitment Status : Completed
First Posted : May 14, 2015
Results First Posted : May 17, 2018
Last Update Posted : February 17, 2021
Sponsor:
Information provided by (Responsible Party):
Biogen

Tracking Information
First Submitted Date  ICMJE May 1, 2015
First Posted Date  ICMJE May 14, 2015
Results First Submitted Date  ICMJE October 6, 2016
Results First Posted Date  ICMJE May 17, 2018
Last Update Posted Date February 17, 2021
Actual Study Start Date  ICMJE May 31, 2015
Actual Primary Completion Date October 31, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • Number of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) [ Time Frame: For Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3 ]
    An AE was any untoward medical occurrence attributed to study drug in a participant who received study drug. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
  • Number of Participants With Laboratory Abnormalities [ Time Frame: Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3 ]
    Hemoglobin(Hgb),hematocrit,red blood cell(RBC):less than(<)0.8*lower limit of normal(LLN), MCV,MCH,MCHC,MPV:<0.9*LLN or >1.1*upper limit of normal(ULN), platelet:<0.5*LLN or >1.75*ULN, white blood cell(WBC):<0.6*LLNor>1.5*ULN, lymphocyte,neutrophil,total neutrophil:<0.8*LLN or >1.2*ULN,basophil,eosinophil,monocyte:>1.2*ULN; PTT, PT:>1.1*ULN,Fibrinogen<0.75*ULNor>1.25ULN; total, direct, indirect bilirubin >1.5*ULN,aspartate aminotransferase,alanine aminotransferase,gamma-glutamyl transferase,alkaline phosphatase:> 3.0*ULN,total protein,albumin:<0.8*LLN or >1.2*ULN;blood urea nitrogen,creatinine:>1.3*ULN,uric acid>1.2*ULN;sodium:<0.95*LLN or>1.05*ULN,potassium,chloride, calcium,magnesium,bicarbonate:<0.9*LLN or >1.1*ULN, phosphate<0.8*LLN or >1.2*ULN; glucose <0.6*LLN or >1.5*ULN,creatine kinase>2.0*ULN;urine(specific gravity<1.003or>1.030,pH <4.5or>8,glucose,ketone,protein,blood/Hgb,bilirubin,leukocyte esterase,crystals>=1,RBC,WBC >=20*ULN,bacteria>20);CSF (WBC>=6,RBC>0,Albumin>35).
  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3 ]
    Criteria for clinically significant change from baseline in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP greater than or equal to (>=)30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.
  • Number of Participants With Abnormal 12-Lead Electrocardiogram (ECG) Findings [ Time Frame: Cohort 1 and 2: Baseline up to Week 8, Cohort 3: Baseline up to Week 2, Cohort 4: Baseline up to Week 3 ]
    ECG parameters included maximum pulse rate (PR) interval, QRS interval, and corrected QT interval using Fridericia's formula (QTcF). Criteria for abnormal ECG: Maximum PR interval >=300 milliseconds (msec) or >=25 percent increase when baseline is >200 msec and >=50 percent increase when baseline is less than or equal to (=<) 200 msec; QRS interval >=140 msec or >=50 percent increase from baseline (IFB); and QTcF 30<=change<60 or change>=60 msec increase. The number of participants with abnormal ECG findings are reported.
  • Change From Baseline in Bond and Lader Visual Analogue Scale (BL-VAS) at 2 Hours Post Dose in Cohorts 1 and 2 [ Time Frame: Baseline, Day 1: 2 hours post dose ]
    The BL-VAS monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) contentment (average of 2 items [total range 0 to 100, where higher scores indicated more contentment]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1 of the first Period.
  • Change From Baseline in Bond and Lader Visual Analogue Scale (BL-VAS) at 6 Hours Post Dose in Cohorts 1 and 2 [ Time Frame: Baseline, Day 1: 6 hours post dose ]
    The BL-VAS monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) contentment (average of 2 items [total range 0 to 100, where higher scores indicated more contentment]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1 of the first Period.
  • Change From Baseline in Bond and Lader Visual Analogue Scale (BL-VAS) at 48 Hours Post Dose in Cohorts 1 and 2 [ Time Frame: Baseline, Day 3: 48 hours post dose ]
    The BL-VAS monitored the subjective mood of each participant on 16 mood scales. Participants were asked to indicate on the VAS scale ranging from 0 to 100 mm about how they felt at the moment the scale was administered (example, alert/drowsy; calm/excited; content/tensed). The individual responses from the 16 mood scales were then combined to make three affective dimensions/subscales a) alertness (average of 9 items [total range 0 to 100, where each item is ordered so that higher scores indicated more alertness]), b) contentment (average of 2 items [total range 0 to 100, where higher scores indicated more contentment]), and c) calmness (average of 5 items [total range 0 to 100, where higher scores indicated more calmness]). Baseline is defined as the last available recording prior to dosing on Day 1 of the first Period.
  • Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) at 2 Hours Post Dose in Cohorts 1 and 2 [ Time Frame: Baseline, Day 1: 2 hours post dose ]
    ESRS is a clinician rated scale to assess parkinsonism,dystonia,dyskinesia,akathisia.The ESRS consists of 4 subscales and 4 clinicians global impressions-severity scales(CGI-S scales):I)a questionnaire of extrapyramidal symptoms or drug-induced movement disorders(a series of 4-point Likert scale questions with 0=Absent and 3=Severe);II)an examination of Parkinsonism and akathisia(7-point Likert scale with 0=Absent,6=extremely severe);III)an examination of dystonia(7-point Likert scale with 0=Absent,6=extremely severe);IV)an examination of dyskinesia(7-point Likert scale with 0=normal,6=most severe);V)toVIII)CGI-S scales(9-point Likert scale with 0=Absent,8=extremely severe)of tardive dyskinesia,parkinsonism,dystonia,akathisia.ESRS-Parkinsonism:total score range:0 to 14 where higher scores indicates greater severity;ESRS-dystonia:total score range:0 to 14 where higher scores indicates greater severity.Change from baseline was only observed in examination of parkinsonism and dystonia.
  • Change From Baseline in Extrapyramidal Symptom Rating Scale (ESRS) at 48 Hours Post Dose in Cohorts 1 and 2 [ Time Frame: Baseline, Day 1: 48 hours post dose ]
    ESRS is a clinician rated scale to assess parkinsonism,dystonia,dyskinesia,akathisia.The ESRS consists of 4 subscales and 4 clinicians global impressions-severity scales(CGI-S scales):I)a questionnaire of extrapyramidal symptoms or drug-induced movement disorders(a series of 4-point Likert scale questions with 0=Absent and 3=Severe);II)an examination of Parkinsonism and akathisia(7-point Likert scale with 0=Absent,6=extremely severe);III)an examination of dystonia(7-point Likert scale with 0=Absent,6=extremely severe);IV)an examination of dyskinesia(7-point Likert scale with 0=normal,6=most severe);V)toVIII)CGI-S scales(9-point Likert scale with 0=Absent,8=extremely severe)of tardive dyskinesia,parkinsonism,dystonia,akathisia.ESRS-Parkinsonism:total score range:0 to 14 where higher scores indicates greater severity;ESRS-dystonia:total score range:0 to 14 where higher scores indicates greater severity.Change from baseline was only observed in examination of parkinsonism and dystonia.
Original Primary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • Change from baseline in extrapyramidal Symptom Rating Scale (ESRS) for all periods [ Time Frame: Day 0, Day 1 hr 2 and 6, Day 3 hr 48 ]
    An objective measurement system to assess the extent of damage to the extrapyramidal system and the motor functions that it controls.
  • Change from baseline in Bond and Lader Visual Analogue Scales (BL-VAS) for all periods [ Time Frame: Day 0, Day 1 hr 2, Day 3 hr 48 ]
    The Bond-Lader Visual Analogue Scales of Mood and Alertness is a questionnaire of 16 bi-polar 10 cm analogue scales that derives three factor scores: Self-rated Alertness, Calmness and Contentment
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2018)
  • Maximum Observed Plasma Concentration (Cmax) of PF-05251749 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of PF-05251749 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose ]
    Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (Clast ).
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of PF-05251749 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose ]
    AUC (0 -∞) = Area under the plasma concentration- time profile from time zero extrapolated to infinite time. It was calculated as AUC last + (C last*/k el), where C last* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of PF-05251749 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose ]
  • Plasma Decay Half-Life (t1/2) of PF-05251749 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose ]
    Terminal elimination half-life (t1/2). It was calculated as dividing the natural logarithm to the base e (Log e)*2/k el, where k el is the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
  • Apparent Oral Clearance (CL/F) of PF-05251749 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood.
  • Apparent Volume of Distribution (Vz/F) of PF-05251749 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Milled and Unmilled PF-05251749: Cohort 4 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose ]
    Area under the plasma concentration-time profile from time zero to the time of last quantifiable concentration (Clast).
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of Milled and Unmilled PF-05251749: Cohort 4 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose ]
    AUC (0 -∞) = Area under the plasma concentration- time profile from time zero extrapolated to infinite time. It was calculated as AUC last + (C last*/k el), where C last* was the predicted plasma concentration at the last quantifiable time point estimated from the log-linear regression analysis.
  • Maximum Observed Plasma Concentration (Cmax) of Milled and Unmilled PF-05251749: Cohort 4 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose ]
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) of Milled and Unmilled PF-05251749: Cohort 4 [ Time Frame: Predose, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, and 48 hours post dose ]
  • Area Under the Curve From Time Zero to Last Quantifiable Cerebrospinal Fluid (CSF) Concentration (AUClast) of PF-05251749 [ Time Frame: Predose, 1.5, 2.5, 4, and 8 hours post dose ]
    Area under the CSF concentration-time profile from time zero to the time of last quantifiable concentration (Clast).
  • Area Under the Curve From Time Zero to Extrapolated Cerebrospinal Fluid (CSF) Infinite Time [AUC (0 - ∞)] of PF-05251749 [ Time Frame: Predose, 1.5, 2.5, 4, and 8 hours post dose ]
    AUC (0 -∞) = Area under the CSF concentration- time profile from time zero extrapolated to infinite time. It was calculated as AUC last + (C last*/k el), where C last* was the predicted CSF concentration at the last quantifiable time point estimated from the log-linear regression analysis.
  • Maximum Observed Cerebrospinal Fluid (CSF) Concentration (Cmax) of PF-05251749 [ Time Frame: Predose, 1.5, 2.5, 4, and 8 hours post dose ]
  • Time to Reach Maximum Observed Cerebrospinal Fluid (CSF) Concentration (Tmax) of PF-05251749 [ Time Frame: Predose, 1.5, 2.5, 4, and 8 hours post dose ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 11, 2015)
  • Maximum Observed Plasma Concentration (Cmax) after single dose for all periods [ Time Frame: Day 1 hr 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 ]
    Cmax after a single dose
  • Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) after single dose for all periods [ Time Frame: Day 1 hr 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 ]
    Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) after single dose
  • Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - inf)] after single dose for all periods [ Time Frame: Day 1 hr 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 ]
    AUC (0 - inf)= Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0 - inf). It is obtained from AUC (0 - t) plus AUC (t - inf) after single dose
  • Time to Reach Maximum Observed Plasma Concentration (Tmax) after single dose for all periods [ Time Frame: Day 1 hr 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 ]
    Tmax after single dose
  • Plasma Decay Half-Life (t1/2) after single dose for all periods [ Time Frame: Day 1 hr 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 ]
    Plasma decay half-life is the time measured for the plasma concentration to decrease by one half after single dose
  • Apparent Oral Clearance (CL/F) after single dose for all periods [ Time Frame: Day 1 hr 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 ]
    Clearance of a drug is a measure of the rate at which a drug is metabolized or eliminated by normal biological processes. Clearance obtained after oral dose (apparent oral clearance) is influenced by the fraction of the dose absorbed. Clearance was estimated from population pharmacokinetic (PK) modeling. Drug clearance is a quantitative measure of the rate at which a drug substance is removed from the blood after single dose
  • Apparent Volume of Distribution (Vz/F) after single dose for all periods [ Time Frame: Day 1 hr 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, Day 2 hr 24 and 36, Day 3 hr 48 ]
    Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired plasma concentration of a drug. Apparent volume of distribution after oral dose (Vz/F) is influenced by the fraction absorbed.
  • Maximum Observed Cerebrospinal fluid (CSF) Concentration (Cmax) after single dose [ Time Frame: Day 1 hr 1.5, 2.5, 4 and 8 ]
    Cmax after a single dose
  • Area Under the Curve From Time Zero to Last Quantifiable Cerebrospinal fluid (CSF) Concentration (AUClast) after single dose [ Time Frame: Day 1 hr 1.5, 2.5, 4 and 8 ]
    Area under the Cerebrospinal fluid (CSF) concentration time-curve from zero to the last measured concentration (AUClast) after single dose
  • Time to Reach Maximum Observed Cerebrospinal fluid (CSF) Concentration (Tmax) after single dose [ Time Frame: Day 1 hr 1.5, 2.5, 4 and 8 ]
    Tmax after single dose
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety, Tolerability and Pharmacokinetics of BIIB118 (PF-05251749)
Official Title  ICMJE A Phase 1, Randomized, Double Blind, Placebo Controlled Study To Investigate The Safety, Tolerability, Pharmacokinetics And Relative Bioavailability Of Single Escalating Oral Doses Of Pf-05251749 In Healthy Adult Subjects
Brief Summary This is a First in human (FIH) single ascending dose study to evaluate the safety, tolerability and pharmacokinetics (PKs) of BIIB118 following single oral doses in healthy human subjects
Detailed Description This study was previously posted by Pfizer. In March, 2020, sponsorship of the trial was transferred to Biogen.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Healthy
Intervention  ICMJE
  • Drug: BIIB118
    Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 3 mg, 30 mg, 200 mg, 800 mg and placebo
    Other Name: PF-05251749
  • Drug: BIIB118
    Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 10 mg, 100 mg, 400 mg, and placebo
    Other Name: PF-05251749
  • Drug: BIIB118
    Single dose (Maximum Tolerated Dose) of BIIB118 as extemporaneously prepared solution/suspension
    Other Name: PF-05251749
Study Arms  ICMJE
  • Experimental: Single Ascending Dose-1 (Part A)
    Single ascending doses of BIIB118 administered to healthy volunteers in a cross over study design
    Intervention: Drug: BIIB118
  • Experimental: Single Ascending Dose-2 (Part A)
    Single ascending doses of BIIB118 administered to healthy volunteers in a cross over study design
    Intervention: Drug: BIIB118
  • Experimental: Single Dose Cerebrospinal Fluid (Part B)
    Single maximum dose from Part A of BIIB118 administered to healthy volunteers to assess the PK of BIIB118 in CSF
    Intervention: Drug: BIIB118
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 30, 2015)
32
Original Estimated Enrollment  ICMJE
 (submitted: May 11, 2015)
38
Actual Study Completion Date  ICMJE October 31, 2015
Actual Primary Completion Date October 31, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

•Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests).

Female subjects of non-childbearing potential must meet at least one of the following criteria:

  1. Achieved postmenopausal status, defined as follows: cessation of regular menses for at least 12 consecutive months with no alternative pathological or physiological cause; and have a serum follicle-stimulating hormone (FSH) level confirming the post-menopausal state;
  2. Have undergone a documented hysterectomy and/or bilateral oophorectomy;
  3. Have medically confirmed ovarian failure. All other female subjects (including females with tubal ligations and females that do NOT have a documented hysterectomy, bilateral oophorectomy and/or ovarian failure) will be considered to be of childbearing potential.

    • Body Mass Index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg (110 lbs).
    • Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
    • Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

  • Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
  • Treatment with an investigational drug within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study medication (whichever is longer).
  • Screening supine blood pressure >= 140 mm Hg (systolic) or >=90 mm Hg (diastolic), following at least 5 minutes of rest. If BP is >=140 mm Hg (systolic) or >=90 mm Hg (diastolic), repeat per local standard operating procedures (SOP). If orthostatic changes are present and deemed to be clinically significant by the investigator, Subject can be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02443740
Other Study ID Numbers  ICMJE B8001001
SAD ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Biogen
Study Sponsor  ICMJE Biogen
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Biogen
PRS Account Biogen
Verification Date February 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP