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Completed

NCT Number: NCT02217917

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Pfizer Clinical Research Unit

Brussels, B-1070, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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).
  • 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.

Treatment and study plan

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).

Placebo

Drug

Matched Placebo administered as single dose subcutaneously with rHuPH20.

Primary outcomes

  1. Assessment of adverse events (AEs)

    Time frame: Baseline up to 7 days of dosing

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

    Time frame: Baseline up to 7 days of dosing

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

    Time frame: Baseline up to 7 days of dosing

  4. Assessment of clinical laboratory tests

    Time frame: Baseline up to 7 days of dosing

Secondary outcomes

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

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

    Time frame: 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

  5. Dose-Normalized Cmax for rivipansel following single dose

    Time frame: 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

  6. Dose-Normalized AUClast for rivipansel

    Time frame: 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

  7. Dose-Normalized AUCinf for rivipansel

    Time frame: 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

  8. Plasma Decay Half-Life (t1/2) for rivipansel following single dose

    Time frame: 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

  9. Apparent Clearance (CL/F) for rivipansel following single dose

    Time frame: 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

  10. Apparent Volume of Distribution (Vz/F) for rivipansel following single dose

    Time frame: 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

  11. Maximum Observed Plasma Concentration (Cmax) for rivipansel following multiple dose

    Time frame: Days 1, 7

  12. Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following multiple dose

    Time frame: Days 1, 7

  13. Area Under the Curve from Time Zero to end of dosing interval (AUCtau) for rivipansel following multiple dose administration, where tau is 12 hours

    Time frame: Days 1, 7

  14. Dose-Normalized Cmax for rivipansel following multiple dose administration

    Time frame: Days 1, 7

  15. Dose-Normalized AUCtau for rivipansel following multiple dose administration

    Time frame: Days 1, 7

  16. Plasma Decay Half-Life (t1/2) for rivipansel following multiple dose

    Time frame: Day 7

  17. Minimum Observed Plasma Concentration (Cmin) for rivipansel following multiple dose

    Time frame: Day 7

  18. Apparent Clearance (CL/F) for rivipansel following multiple dose

    Time frame: Day 7

  19. Peak to Trough Ratio (PTR) of plasma concentration for rivipanselmultiple dose administration

    Time frame: Day 7

  20. Accumulation ratio for Area Under the Curve during the dosing interval (Rac) for rivipansel

    Time frame: Day 7

Sponsors and collaborators

Lead sponsor

GlycoMimetics Incorporated

Industry

Registry information

Official study title

A Phase 1, Randomized, Double Blind, Sponsor Open, Placebo Controlled, Single And Multiple Ascending Dose Study To Evaluate The Safety, Tolerability, And Pharmacokinetics Of Rivipansel (pf 06460031) Following Subcutaneous Administration With Rhuph20 (pf 06744547) In Healthy Subjects

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 15, 2014
Registry last updated
Jun 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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