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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02217917
• Date of registration: 13/08/2014
• Prospective Registration: Yes
• Primary sponsor: GlycoMimetics Incorporated
• Public title: Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects
• Scientific 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
• Date of first enrolment: October 2015
• Target sample size: 27
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02217917
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: Phase 1

Countries of recruitment

Belgium

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

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.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Healthy

Intervention(s)

Drug: Placebo

Drug: Rivipansel

Primary Outcome(s)

Assessment of adverse events (AEs) [Time Frame: Baseline up to 7 days of dosing]

Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG) [Time Frame: Baseline up to 7 days of dosing]

Assessment of clinical laboratory tests [Time Frame: Baseline up to 7 days of dosing]

Assessment of vital signs (including blood pressure and pulse rate) [Time Frame: Baseline up to 7 days of dosing]

Secondary Outcome(s)

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]

Peak to Trough Ratio (PTR) of plasma concentration for rivipanselmultiple dose administration [Time Frame: Day 7]

Accumulation ratio for Area Under the Curve during the dosing interval (Rac) for rivipansel [Time Frame: Day 7]

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]

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]

Dose-Normalized AUCtau for rivipansel following multiple dose administration [Time Frame: Days 1, 7]

Maximum Observed Plasma Concentration (Cmax) for rivipansel following multiple dose [Time Frame: Days 1, 7]

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]

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]

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]

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]

Apparent Clearance (CL/F) for rivipansel following multiple dose [Time Frame: Day 7]

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]

Dose-Normalized Cmax for rivipansel following multiple dose administration [Time Frame: Days 1, 7]

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]

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]

Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following multiple dose [Time Frame: Days 1, 7]

Minimum Observed Plasma Concentration (Cmin) for rivipansel following multiple dose [Time Frame: Day 7]

Plasma Decay Half-Life (t1/2) for rivipansel following multiple dose [Time Frame: Day 7]

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]

Secondary ID(s)

B5201007

2014-002748-41

Source(s) of Monetary Support

Please refer to primary and secondary sponsors