HealthyPhase 1NCT02217917
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous Rivipansel With rHuPH20 in Healthy Subjects
A Phase 1 study testing Rivipansel in people with Healthy, run by GlycoMimetics Incorporated at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Rivipansel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2015to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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
- Being tested
- Rivipansel, Placebo
- Keywords
- Healthy subjects, Randomized, Double-blind, Single ascending dose, Multiple ascending dose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivipanselDrug
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).
PlaceboDrug
Matched Placebo administered as single dose subcutaneously with rHuPH20.
RivipanselDrug
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).
RivipanselDrug
Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).
PlaceboDrug
Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Single ascending dose in 3 period cross-over design (with optional 4th period) Receives: Drug: Rivipansel; Drug: Placebo |
| Cohort 2 | Experimental | Multiple ascending dose Receives: Drug: Rivipansel; Drug: Placebo |
| Cohort 3 | Experimental | Multiple ascending dose Receives: Drug: Rivipansel; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of adverse events (AEs)
Measured: Baseline up to 7 days of dosing
Assessment of cardiac conduction intervals as assessed via 12-lead electrocardiogram (ECG)
Measured: Baseline up to 7 days of dosing
Assessment of vital signs (including blood pressure and pulse rate)
Measured: Baseline up to 7 days of dosing
Assessment of clinical laboratory tests
Measured: Baseline up to 7 days of dosing
Secondary outcomes (20)
Maximum Observed Plasma Concentration (Cmax) for rivipansel following single dose
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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 AUClast for rivipansel
Measured: 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
Measured: 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
Plasma Decay Half-Life (t1/2) for rivipansel following single dose
Measured: 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 single dose
Measured: 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
Measured: 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 multiple dose
Measured: Days 1, 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following multiple dose
Measured: Days 1, 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
Measured: Days 1, 7
Dose-Normalized Cmax for rivipansel following multiple dose administration
Measured: Days 1, 7
Dose-Normalized AUCtau for rivipansel following multiple dose administration
Measured: Days 1, 7
Plasma Decay Half-Life (t1/2) for rivipansel following multiple dose
Measured: Day 7
Minimum Observed Plasma Concentration (Cmin) for rivipansel following multiple dose
Measured: Day 7
Apparent Clearance (CL/F) for rivipansel following multiple dose
Measured: Day 7
Peak to Trough Ratio (PTR) of plasma concentration for rivipanselmultiple dose administration
Measured: Day 7
Accumulation ratio for Area Under the Curve during the dosing interval (Rac) for rivipansel
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2014 (estimated)
- Study startOct 2015
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlycoMimetics Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02217917
- Sponsor's protocol ID
- B5201007
- Other IDs
- 2014-002748-41, 2014
- Status last verified
- Jun 2020
- First submitted
- 13 Aug 2014
- Last updated
- 18 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02217917
- Acronym / sponsor ID
- B5201007
- Conditions
- Healthy
- Keywords
- Healthy subjects, Randomized, Double-blind, Single ascending dose, Multiple ascending dose
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- GlycoMimetics IncorporatedIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 15 Aug 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: Rivipansel, Drug: PlaceboSingle ascending dose in 3 period cross-over design (with optional 4th period) |
| Cohort 2 | Experimental | Drug: Rivipansel, Drug: PlaceboMultiple ascending dose |
| Cohort 3 | Experimental | Drug: Rivipansel, Drug: PlaceboMultiple ascending dose |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivipanselRivipansel 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). | Drug | Cohort 1 |
| PlaceboMatched Placebo administered as single dose subcutaneously with rHuPH20. | Drug | Cohort 1 |
| RivipanselRivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data). | Drug | Cohort 2 |
| RivipanselRivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data). | Drug | Cohort 3 |
| PlaceboMatched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. | Drug | Cohort 2, Cohort 3 |
Primary outcome
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 vital signs (including blood pressure and pulse rate)
Time frame: Baseline up to 7 days of dosing
Assessment of clinical laboratory tests
Time frame: Baseline up to 7 days of dosing
20 secondary outcomes
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
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
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
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
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
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 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
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
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
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 multiple dose
Time frame: Days 1, 7
Time to Reach Maximum Observed Plasma Concentration (Tmax) for rivipansel following multiple dose
Time frame: Days 1, 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 Cmax for rivipansel following multiple dose administration
Time frame: Days 1, 7
Dose-Normalized AUCtau for rivipansel following multiple dose administration
Time frame: Days 1, 7
Plasma Decay Half-Life (t1/2) for rivipansel following multiple dose
Time frame: Day 7
Minimum Observed Plasma Concentration (Cmin) for rivipansel following multiple dose
Time frame: Day 7
Apparent Clearance (CL/F) for rivipansel following multiple dose
Time frame: Day 7
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rivipansel in people with Healthy, run by GlycoMimetics Incorporated at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of adverse events (AEs) (time frame: Baseline up to 7 days of dosing). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2020.