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A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function

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ClinicalTrials.gov Identifier: NCT02871570
Recruitment Status : Completed
First Posted : August 18, 2016
Results First Posted : November 28, 2018
Last Update Posted : July 9, 2020
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

Tracking Information
First Submitted Date  ICMJE August 15, 2016
First Posted Date  ICMJE August 18, 2016
Results First Submitted Date  ICMJE February 14, 2018
Results First Posted Date  ICMJE November 28, 2018
Last Update Posted Date July 9, 2020
Actual Study Start Date  ICMJE September 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • Number of Participants With Post-baseline Clinically Significant Findings in Physical Examinations [ Time Frame: Day 5 ]
    A full physical examination was performed for each participant, and it included head, ears, eyes, nose, mouth, skin, heart and lung examinations, lymph nodes and gastrointestinal, musculoskeletal, and neurological systems. Clinical significance of laboratory findings was determined by the investigator.
  • Number of Participants With Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: Day 1 to follow-up visit (28-31 days after administration of study medication on Day 1) ]
    An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a product or medical device, regardless of its causal relationship with study treatment. 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; was life-threatening (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent AEs were events between administration of study medication and up to follow-up visit (28-31 days after administration) that were absent before treatment or that worsened after treatment. AEs included both serious and non-serious AEs.
  • Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Summarization Criteria [ Time Frame: Day 5 ]
    Maximum absolute values and increases from baseline were summarized for PR interval (time from the beginning of P wave to the start of QRS complex, corresponding to the end of atrial depolarization and onset of ventricular depolarization), QRS duration (time from Q wave to the end of S wave, corresponding to ventricle depolarization), and QTcF interval (time from the beginning of Q wave to the end of T wave corresponding to electrical systole corrected for heart rate using Fridericia's formula). Number of participants with ECG findings meeting the following criteria is presented: (1) PR interval >=300 msec; (2) QRS duration >=200 msec; (3) QTcF interval: 450 to <480 msec; (4) QTcF interval: 480 to <500 msec; (5) QTcF interval >=500 msec; (6) PR interval percent increase from baseline >=25/50 percent; (7) QRS duration percent increase from baseline >=50 percent; (8) QTcF interval increase from baseline: 30 to <60 msec; (9) QTcF interval increase from baseline >=60 msec.
  • Number of Participants With Vital Signs Data Meeting Pre-defined Summarization Criteria [ Time Frame: Day 1 to Day 5 ]
    Absolute values and changes from baseline (increase and decrease) were summarized for supine diastolic blood pressure (DBP), supine systolic blood pressure (SBP), and supine pulse rate. Number of participants with vital signs findings meeting the following criteria is presented: (1) supine DBP <50 millimeters of mercury (mm Hg); (2) supine DBP >90 mm Hg; (3) supine SBP <90 mm Hg; (4) supine SBP >140 mm Hg (for normal hepatic function group); (5) supine SBP >160 mm Hg (for moderate hepatic impairment group); (6) supine pulse rate < 40 beats per minute (bpm); (7) supine pulse rate >120 bpm; (8) supine DBP increase from baseline >=20 mm Hg; (9) supine SBP increase from baseline >=30 mmHg; (10) supine DBP decrease from baseline >=20 mm Hg; (11) supine SBP decrease from baseline >=30 mm Hg.
  • Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) [ Time Frame: Day 5 ]
    Laboratory tests included: hematology (hemoglobin, hematocrit, red and white blood cell count, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, platelet count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes, prothrombin time/international normalized ratio), chemistry (blood urea nitrogen/urea and creatinine, fasting glucose, calcium, sodium, potassium, chloride, total carbon dioxide, aspartate and alanine aminotransferase, total bilirubin, alkaline phosphatase, uric acid, albumin, total protein), urinalysis (pH, qualitative glucose, protein, and blood, ketones, nitrites, leukocyte esterase, urobilinogen, urine bilirubin, and microscopy), and other tests (follicle stimulating hormone, urine drug test and serologic tests on human immunodeficiency virus-1 antibody, Hepatitis B surface antigen and hepatitis C antibody). Abnormality was determined by the investigator using widely accepted criteria in clinical practice.
  • Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Rivipansel [ Time Frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 ]
    AUCinf was calculated as AUClast + (Clast*/kel), where Clast* was the predicted plasma concentration at the last quantifiable time point estimated from the log linear regression analysis, kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration-time curve.
  • Total Clearance From Plasma (CL) of Rivipansel [ Time Frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 ]
    CL of rivipansel was calculated as dose/AUCinf, where AUCinf referred to the area under the plasma concentration-time profile from time 0 extrapolated to the infinite time.
Original Primary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
  • Area under the concentration-time curve from time 0 to infinity or area under the concentration-time curve from time 0 to the time of the last quantifiable concentration, as data permit [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours following single dose administration ]
  • Clearance (CL) [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours following single dose administration ]
  • Physical examination [ Time Frame: Baseline up to 96 hours ]
  • Assessment of adverse events [ Time Frame: Baseline up to 28 days ]
  • Assessment of 12-lead electrocardiograms [ Time Frame: Baseline up to 96 hours ]
  • Assessment of vital signs [ Time Frame: Baseline up to 96 hours ]
  • Assessment of laboratory tests [ Time Frame: Baseline up to 96 hours ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2018)
  • Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rivipansel [ Time Frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 ]
    Area under the plasma concentration-time profile from time 0 to the time of the last quantifiable concentration (AUClast) of rivipansel was determined using a linear/log trapezoidal method.
  • Maximum Observed Concentration (Cmax) of Rivipansel [ Time Frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 ]
  • Terminal Half-Life of Rivipansel [ Time Frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 ]
    Terminal half-life of rivipansel was calculated as loge(2)/kel, where kel was the terminal phase rate constant calculated by a linear regression of the log-linear concentration time curve.
  • Volume of Distribution at Steady State (Vss) of Rivipansel [ Time Frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 ]
    Vss of rivipansel was calculated as CL*MRT, where MRT was the mean residence time and CL was the clearance from plasma.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 17, 2016)
  • Area under the concentration-time curve from time 0 to the time of the last quantifiable concentration [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours following single dose administration ]
  • Peak or maximum observed concentration [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours following single dose administration ]
  • Terminal half life [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours following single dose administration ]
  • Volume of distribution at steady state [ Time Frame: Samples are collected pre-dose and at 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72 and 96 hours following single dose administration ]
Current Other Pre-specified Outcome Measures
 (submitted: February 14, 2018)
Time for Maximum Observed Concentration (Tmax) of Rivipansel [ Time Frame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1 ]
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Effect of IV Doses of Rivipansel in Subjects With Moderate Hepatic Impairment and in Healthy Subjects With Normal Hepatic Function
Official Title  ICMJE A Phase 1, Non-randomized, Open-label, Parallel-group Single-dose Study To Evaluate The Pharmacokinetics, Safety, And Tolerability Of Intravenous Rivipansel (Pf-06460031) In Subjects With Moderate Hepatic Impairment And In Healthy Subjects With Normal Hepatic Function
Brief Summary The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK and safety.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Moderate Hepatic Impairment
  • Normal Hepatic Function
Intervention  ICMJE Drug: Rivipansel
A single dose of IV Rivipansel over 20 minutes
Other Name: GMI-1070
Study Arms  ICMJE
  • Experimental: Moderate Hepatic Impairment
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
  • Experimental: Normal Hepatic Function
    A single dose of IV Rivipansel over 20 minutes
    Intervention: Drug: Rivipansel
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: August 17, 2016)
16
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Female subjects of non-childbearing potential or male subjects

    • Body Mass Index (BMI) of 17.5 to 40.0 kg/m2
    • Normal Hepatic function for the healthy subjects
    • Stable Hepatic Impairment for the subjects with moderate hepatic impairment

Exclusion Criteria:

  • Treatment with an investigational drug within 30 days of the dose of study medication
  • Pregnant females, breastfeeding female subjects and male subjects with partners currently pregnant
  • Use of herbal supplements in the 28 days prior to the dose of study medication
  • Blood donation (excluding plasma donation) of approximately 1 pint or more within 56 days prior to study medication
  • A positive urine drug screen for illicit drugs
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older 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 NCT02871570
Other Study ID Numbers  ICMJE B5201006
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GlycoMimetics Incorporated
Study Sponsor  ICMJE GlycoMimetics Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account GlycoMimetics Incorporated
Verification Date June 2020

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