Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects

NCT02217917 | Completed Phase 1

• 2 other identifiers: B52010072014-002748-41
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

This is a 2 part study designed to provide an initial assessment on the safety, tolerability, and PK of rivipansel, following single ascending (Part 1) and multiple ascending dosing (Part 2) given subcutaneously with rHuPH20, in healthy subjects. Part 1 of the study will be conducted using a cross-over design while Part 2 of the study will be conducted using a parallel design.

Conditions

Healthy

Keywords

Healthy subjects; Randomized; Double-blind; Single ascending dose; Multiple ascending dose

Outcome Measures

Primary Outcomes (4)

• Assessment of adverse events (AEs)

  Baseline up to 7 days of dosing

• Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG)

  Baseline up to 7 days of dosing

• Assessment of vital signs (including blood pressure and pulse rate)

  Baseline up to 7 days of dosing

• Assessment of clinical laboratory tests

  Baseline up to 7 days of dosing

Secondary Outcomes (20)

• Maximum Observed Plasma Concentration (Cmax) for rivipansel following single dose

  Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration

• Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following single dose

  Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration

• Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) for rivipansel following single dose

  Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration

• Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUCinf) for rivipansel following single dose

  Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration

• Dose-Normalized Cmax for rivipansel following single dose

  Samples are collected pre-dose and at 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 H following single dose administration

Study Arms (3)

Cohort 1

EXPERIMENTAL

Single ascending dose in 3 period cross-over design (with optional 4th period)

Drug: Rivipansel; Drug: Placebo

Cohort 2

EXPERIMENTAL

Multiple ascending dose

Drug: Rivipansel; Drug: Placebo

Cohort 3

EXPERIMENTAL

Multiple ascending dose

Drug: Rivipansel; Drug: Placebo

Interventions

Rivipansel DRUG

Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel). The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).

Cohort 1

Placebo DRUG

Matched Placebo administered as single dose subcutaneously with rHuPH20.

Cohort 1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and/or female subjects of non-childbearing potential between the ages of 18 and 55 years, inclusive.
• Body Mass Index 17.5 - 30.5 kg/m2 and body weight \>50 kg at Screening.
• Normal skin without potentially obscuring features in the area intended for infusion.
• Subjects willing to defer receiving prophylactic immunizations (eg, influenza or pneumococcal vaccines) during the study.
• Evidence of a personally signed and dated informed consent document indicating that the subject or a legally acceptable representative has been informed of all pertinent aspects of the study

You may not qualify if:

• 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).
• History of a recent major surgery (within 3 months of screening).
• Serious infection within 1 month of screening.
• Subjects with chronic skin condition that may interfere in the assessment of emergent safety data.
• A positive urine drug screen.
• Known sensitivity to hyaluronidases.
• History of hepatitis or positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) or hepatitis C antibodies (HCV).
• Unwilling or unable to comply with the Lifestyle Guidelines described in this protocol.
• Subjects who are investigational site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the Investigator, or subjects who are Pfizer employees directly involved in the conduct of the study.

Sponsors & Collaborators

• GlycoMimetics Incorporated: lead

Study Sites (1)

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Location

MeSH Terms

Interventions

rivipansel

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2014
• First Posted: August 15, 2014
• Study Start: October 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: June 18, 2020

Record last verified: 2020-06

Locations

BE (1)