Clinical trial NCT02871570: 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: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Moderate Hepatic Impairment
Normal Hepatic Function
Keywords: Hepatic Impairment
Rivipansel
Lead sponsor: GlycoMimetics Incorporated
Sponsor class: INDUSTRY
First posted: 2016-08-18
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this study is to determine the effect of hepatic impairment on rivipansel PK and safety.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Post-baseline Clinically Significant Findings in Physical Examinations
timeFrame: Day 5
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Day 1 to follow-up visit (28-31 days after administration of study medication on Day 1)
measure: Number of Participants With Electrocardiogram (ECG) Data Meeting Pre-defined Summarization Criteria
timeFrame: Day 5
measure: Number of Participants With Vital Signs Data Meeting Pre-defined Summarization Criteria
timeFrame: Day 1 to Day 5
measure: Number of Participants With Laboratory Test Abnormalities (Without Regard to Baseline Abnormality)
timeFrame: Day 5
measure: Area Under the Plasma Concentration-Time Profile From Time 0 Extrapolated to Infinite Time (AUCinf) of Rivipansel
timeFrame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
measure: Total Clearance From Plasma (CL) of Rivipansel
timeFrame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
Secondary outcomes:
measure: Area Under the Plasma Concentration-Time Profile From Time 0 to the Time of the Last Quantifiable Concentration (AUClast) of Rivipansel
timeFrame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
measure: Maximum Observed Concentration (Cmax) of Rivipansel
timeFrame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
measure: Terminal Half-Life of Rivipansel
timeFrame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
measure: Volume of Distribution at Steady State (Vss) of Rivipansel
timeFrame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
Other outcomes:
measure: Time for Maximum Observed Concentration (Tmax) of Rivipansel
timeFrame: Pre-dose, 0.33, 1, 3, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1
Locations:
city: Orlando
country: United States
facility: Orlando Clincial Research Center
state: Florida
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Tammara BK, Ryan K, Plotka A, Shafer FE, Wei H, Readett D, Fang A, Korth-Bradley JM. Effect of Renal or Hepatic Impairment on the Pharmacokinetics, Safety, and Tolerability of Intravenous Rivipansel. Clin Pharmacol Drug Dev. 2020 Nov;9(8):918-928. doi: 10.1002/cpdd.842. Epub 2020 Jun 24.