Anemia, Sickle CellPhase 1NCT01178099

An Assessment of Prasugrel on Healthy Adults and Sickle Cell Adults

A Phase 1 study testing Prasugrel in people with Anemia, Sickle Cell, run by Eli Lilly and Company at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study is to measure the exposure to prasugrel's active metabolite and the pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD). Read more about this study

Who is it for?: Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for: Anemia, Sickle Cell
What is being tested?: Prasugrel
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited Kingdom
Study dates: Jul 2010to Jan 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 60 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Are 50 to 100 kilograms (kg), inclusive, at the time of screening.
Have signed informed consent.
If female, agree to use a reliable method of birth control during the study or are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
Control Subjects - Are healthy adults as determined by medical history, physical examination, and other screening procedures.
Sickle cell disease (SCD) Subjects - Subjects on hydroxyurea must be on a stable dose for the 30 days prior to enrollment without signs of hematologic toxicity at screening.
SCD Subjects - Are adults with SCD (hemoglobin SS [HbSS], Hb S beta0 thalassemia, Hb SC or Hb S beta+ thalassemia genotype) without a diagnosis of acute vaso-occlusive crisis (VOC) requiring medical intervention in an emergency department, infusion center, or as an inpatient) within the month prior to screening.

Who cannot join

Have a concomitant medical illness (for example, terminal malignancy) that, in the opinion of the investigator, is associated with reduced survival over the expected treatment period (approximately 1 month).
Exhibit severe hepatic dysfunction (cirrhosis, portal hypertension, or alanine aminotransferase [ALT] for aspartate aminotransaminase [AST]≥3 times upper limit of normal [ULN]).
Exhibit severe renal dysfunction defined as Cockcroft-Gault creatinine clearance<30 milliliters per minute (ml/min), or requiring chronic dialysis. Creatine clearance = [(140-Age) * Mass (in kg)] \ [72 * Serum creatinine (in milligrams per deciliter [mg/dL])].
Exhibit any contraindication for antiplatelet therapy.
Have a history of intolerance or allergy to approved thienopyridines.
Exhibit any signs or symptoms of an infection.

Show all 24Show fewer

Have a hematocrit <18%.
Exhibit any history of bleeding diathesis, bleeding requiring in-hospital treatment, or papillary necrosis.
Have active internal bleeding.
Have a history of spontaneous bleeding requiring in-hospital treatment.
Have gross hematuria or >300 red blood cells (RBC)/high-powered field (HPF) on urinalysis at the time of screening.
History of previous intraocular hemorrhage which required treatment with surgery or laser, or evidence of active intraocular haemorrhage.
Have a prior history of transient ischemic attack (TIA), ischemic stroke, hemorrhagic stroke or other intracranial hemorrhage.
Have a known history of intracranial neoplasm, arteriovenous malformation, or aneurysm.
Have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding.
Have an international normalized ratio (INR) known to be >1.5 (INR testing not required for study entry).
Have had recent surgery (within 30 days prior to screening) or are scheduled to undergo surgery within the next 60 days.
Have a recent history of clinically significant menorrhagia.
Have used any aspirin, warfarin, or thienopyridine in the 10 days prior to enrollment.
Have used any non-aspirin non-steroidal anti-inflammatory drug (NSAID) in the 3 days prior to enrollment.
Anticipate using aspirin, warfarin, NSAID, thienopyridine or other antiplatelet agent during the study period.
Are women who are known to be pregnant, who have given birth within the past 90 days, or who are breastfeeding.
Regular use of drugs of abuse and/or unacceptable positive findings on urinary drug screening (a positive urinary drug screening for sleep inducers or pain medications in subjects with SCD will be considered as an acceptable finding).
Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device, or are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
London, UK, SE 1 1YR

Other trials in United Kingdom

About this study

Official title: A Pharmacokinetic and Pharmacodynamic Assessment of Prasugrel in Healthy Adults and Adults With Sickle Cell Disease

The purpose of this study is to measure the exposure to prasugrel's active metabolite and the pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD).

Conditions: Anemia, Sickle Cell
Being tested: Prasugrel
Medical subject headings: Anemia, Sickle Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrasugrelDrug
Also called LY650315, CS747, Effient, Efient
Oral, daily for 12 days

Study groups in NCT01178099
Study group	Role	What they receive
Prasugrel	Experimental	Participants received a single 10 milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]). Receives: Drug: Prasugrel

What is being measured

The primary outcome is the main question the study is designed to answer.

Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] for Prasugrel's Active Metabolite, R-138727
The AUC of Prasugrel's active metabolite, R-138727, was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.
Measured: Time of dosing up to 8 hours post-dose on Day 1 and Day 12
Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727
Cmax was observed from the data and used to calculate Geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.
Measured: Day 1, Day 12

Secondary outcomes (13)

Change From Baseline in the Maximum Platelet Aggregation (MPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
MPA to 5 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition.
Measured: Baseline, Day 12
Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
AUC was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.
Measured: Day 1, Day 12
Change From Baseline in the Residual Platelet Aggregation (RPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
RPA is the percentage aggregation as measured by LTA at 6 minutes after the addition of 5 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).
Measured: Baseline, Day 12
Inhibition of Platelet Aggregation (IPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula:
([MPA at baseline - MPA postbaseline] / MPA at baseline) x 100%
Measured: Day 12
Change From Baseline in the Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
MPA to 20 μM ADP was assessed by light transmission aggregometry (LTA), an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance). The LTA results were collected as MPA, for which low values indicate strong platelet inhibition.
Measured: Baseline, Day 12
Change From Baseline in the Residual Platelet Aggregation (RPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
RPA is the percentage aggregation as measured by light transmission aggregometry (LTA) at 6 minutes after the addition of 20 μM ADP. LTA is an assay that measures platelet aggregation by determining the amount of light transmitted through a cuvette containing the platelet-rich plasma stimulated with a platelet activator, such as ADP, relative to platelet-poor plasma (100% light transmittance).
Measured: Baseline, Day 12
Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
IPA is calculated as a percent decrease of maximum platelet aggregation (MPA) from baseline using the following formula:
([MPA at baseline - MPA postbaseline] / MPA at baseline) x 100%
Measured: Day 12
Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
Cmax was observed from the data and used to calculate geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.
Measured: Day 1, Day 12
Change From Baseline in the P2Y12 Reaction Units (PRU) Device Reported P2Y12 Percent Inhibition at Day 12
PRU device reported VerifyNow percent inhibition is reported by Accumetrics VerifyNow™ P2Y12 (VN-P2Y12) assay, a point-of-care device that measures platelet aggregation with single-use, disposable cartridges.
Measured: Baseline, Day 12
Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12
PRI was calculated by vasodilator-associated phosphoprotein (VASP) phosphorylation assay using flow cytometry (FC) and a VASP assay using enzyme-linked immunosorbent assay (ELISA). The PRI indicates the level of P2Y12 inhibition. A low PRI reflects strong inhibition of P2Y12, whereas a high PRI reflects weak/absent inhibition of P2Y12.
Measured: Baseline, Day 12
Change From Baseline in the Area Under the Aggregation Curve at Day 12
AUC to 20 micromolar (μM) adenosine diphosphate (ADP), 6.5μM ADP, Collagen, and thrombin receptor activator for peptide 6 (TRAP-6) were calculated by whole blood multi-electrode aggregometry (MEA) assay. Platelet aggregation was continuously recorded for 5 minutes and quantified as area under the aggregation curve, measured in aggregation units*minutes (AU*min).
Measured: Baseline, Day 12
Change From Baseline in the Percent Aggregation to 20 µM Adenosine Diphosphate (ADP) at Day 12
Percent aggregation was assessed by Plateletworks® ADP assay, a whole blood-based test of platelet aggregation for the assessment of platelet inhibition. The assay determines the change in single platelet count due to activation and aggregation by ADP and inhibition thereof by antiplatelet agents.
Measured: Baseline, Day 12
P2Y12 Reaction Units (PRU)-Derived VerifyNow (VN) Percent Inhibition at Day 12
PRU-derived VN percent inhibition is calculated as a percent decrease of PRU from baseline using the following formula:
([PRU at baseline - PRU at time of post baseline] / PRU at baseline) x 100%
Measured: Day 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2010Jan 2011

First posted9 Aug 2010 (estimated)
Study startJul 2010
Primary completionJan 2011
Study completionJan 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Anemia, Sickle CellStudies of the same condition, open and under way.
More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01178099
Sponsor's protocol ID: 13746
Other IDs: H7T-MC-TAEJ
Status last verified: Jan 2012
First submitted: 6 Aug 2010
Last updated: 15 Feb 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study to Evaluate the Safety and Tolerability of Escalating Doses of Fostamatinib in Subjects With Stable Sickle Cell Disease
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All Anemia, Sickle Cell trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pharmacokinetic and Pharmacodynamic Assessment of Prasugrel in Healthy Adults and Adults With Sickle Cell Disease
ClinicalTrials.gov ID: NCT01178099
Acronym / sponsor ID: 13746
Conditions: Anemia, Sickle Cell
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Eli Lilly and CompanyIndustry (pharma, biotech, devices)
Collaborators: Daiichi Sankyo Co., Ltd.
Study start: Jul 2010
Primary completion: Jan 2011 (actual)
Study completion: Jan 2011 (actual)
First posted: 9 Aug 2010 (estimated)
Results: Posted 15 Feb 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study is to measure the exposure to prasugrel's active metabolite and the pharmacodynamic effects of prasugrel treatment in people with Sickle Cell Disease (SCD).

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Prasugrel	Experimental	Drug: PrasugrelParticipants received a single 10 milligram (mg) dose on Day 1 (single dose [SD]), followed by either 5 mg/day (for participants<60 kilograms [kg]) or 7.5 mg/day (for participants≥60 kg) for an additional 11 days (multiple dose [MD]).

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Are 50 to 100 kilograms (kg), inclusive, at the time of screening.
Have signed informed consent.
If female, agree to use a reliable method of birth control during the study or are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause.
Control Subjects - Are healthy adults as determined by medical history, physical examination, and other screening procedures.
Sickle cell disease (SCD) Subjects - Subjects on hydroxyurea must be on a stable dose for the 30 days prior to enrollment without signs of hematologic toxicity at screening.

Key exclusion criteria (24 listed)

Have a concomitant medical illness (for example, terminal malignancy) that, in the opinion of the investigator, is associated with reduced survival over the expected treatment period (approximately 1 month).
Exhibit severe hepatic dysfunction (cirrhosis, portal hypertension, or alanine aminotransferase [ALT] for aspartate aminotransaminase [AST]≥3 times upper limit of normal [ULN]).
Exhibit severe renal dysfunction defined as Cockcroft-Gault creatinine clearance<30 milliliters per minute (ml/min), or requiring chronic dialysis. Creatine clearance = [(140-Age) * Mass (in kg)] \ [72 * Serum creatinine (in milligrams per deciliter [mg/dL])].
Exhibit any contraindication for antiplatelet therapy.
Have a history of intolerance or allergy to approved thienopyridines.

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
PrasugrelAlso: LY650315, CS747, Effient, EfientOral, daily for 12 days	Drug	Prasugrel

Primary outcome

Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] for Prasugrel's Active Metabolite, R-138727
Time frame: Time of dosing up to 8 hours post-dose on Day 1 and Day 12
The AUC of Prasugrel's active metabolite, R-138727, was calculated through the sampling time of the last quantifiable plasma concentration [AUC(0-tlast)]. Geometric Least Squares (LS) Means were obtained. The log-transformed AUC was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.
Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727
Time frame: Day 1, Day 12
Cmax was observed from the data and used to calculate Geometric Least Squares (LS) Means. The log-transformed Cmax was analyzed with a mixed effect model with dose, population, dose*population interaction as fixed effects, and participant as a random effect.

13 secondary outcomes

Change From Baseline in the Maximum Platelet Aggregation (MPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Time frame: Baseline, Day 12
Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
Time frame: Day 1, Day 12
Change From Baseline in the Residual Platelet Aggregation (RPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Time frame: Baseline, Day 12
Inhibition of Platelet Aggregation (IPA) to 5 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Time frame: Day 12
Change From Baseline in the Maximum Platelet Aggregation (MPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Time frame: Baseline, Day 12
Change From Baseline in the Residual Platelet Aggregation (RPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Time frame: Baseline, Day 12
Inhibition of Platelet Aggregation (IPA) to 20 Micromolar (µM) Adenosine Diphosphate (ADP) at Day 12
Time frame: Day 12
Maximum Concentration (Cmax) of Prasugrel's Inactive Metabolites, R-95913, R-106583, and R-119251
Time frame: Day 1, Day 12
Change From Baseline in the P2Y12 Reaction Units (PRU) Device Reported P2Y12 Percent Inhibition at Day 12
Time frame: Baseline, Day 12
Change From Baseline in the Platelet Reactivity Index (PRI) of Prasugrel at Day 12
Time frame: Baseline, Day 12
Change From Baseline in the Area Under the Aggregation Curve at Day 12
Time frame: Baseline, Day 12
Change From Baseline in the Percent Aggregation to 20 µM Adenosine Diphosphate (ADP) at Day 12
Time frame: Baseline, Day 12
P2Y12 Reaction Units (PRU)-Derived VerifyNow (VN) Percent Inhibition at Day 12
Time frame: Day 12

Results and safety

Results posted to the registry on 15 Feb 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prasugrel Healthy Participants	13	13
Prasugrel Sickle Cell Disease	13	12

Primary outcome: Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] for Prasugrel's Active Metabolite, R-138727

Time frame: Time of dosing up to 8 hours post-dose on Day 1 and Day 12. Least squares mean (95% Confidence Interval). Unit: nanogram*hour per milliliter (ng*h/mL)

Measure	Prasugrel Healthy Participants n = 13	Prasugrel Sickle Cell Disease n = 12
10 mg SD (overall)	68.2 (57.9 to 80.5)	71.5 (60.5 to 84.6)
7.5 mg MD (N=9, 8)	50.4 (42.0 to 60.5)	45.2 (37.2 to 54.8)
5 mg MD (N=4, 4)	39.8 (30.3 to 52.3)	36.0 (27.4 to 47.4)

Prasugrel Healthy Participants vs Prasugrel Sickle Cell Disease: Ratio of Geometric LS Means, SCD:Healthy: 1.05 (90% CI 0.829 to 1.33), Mixed Models Analysis
Prasugrel Healthy Participants vs Prasugrel Sickle Cell Disease: Ratio of Geometric LS Means, SCD:Healthy: 0.895 (90% CI 0.718 to 1.12), Mixed Models Analysis
Prasugrel Healthy Participants vs Prasugrel Sickle Cell Disease: Ratio of Geometric LS Means, SCD:Healthy: 0.905 (90% CI 0.656 to 1.25), Mixed Models Analysis

Population analysed: All participants who received at least 1 dose of the study drug and have evaluable data, excluding participants with an adverse event (AE) of vomiting that occurred at or before 4-hours postdose.

Primary outcome: Maximum Concentration (Cmax) of Prasugrel's Active Metabolite, R-138727

Time frame: Day 1, Day 12. Least squares mean (95% Confidence Interval). Unit: nanogram per milliliter (ng/mL)

Measure	Prasugrel Healthy Participants n = 13	Prasugrel Sickle Cell Disease n = 12
10 mg SD (overall)	67.9 (52.8 to 87.4)	64.7 (50.1 to 83.7)
7.5 mg MD (N=9, 8)	62.5 (47.2 to 82.7)	38.2 (28.4 to 51.5)
5 mg MD (N=4, 4)	40.9 (26.9 to 62.3)	42.0 (27.6 to 63.9)

Prasugrel Healthy Participants vs Prasugrel Sickle Cell Disease: Ratio of Geometric LS Means, SCD:Healthy: 0.953 (90% CI 0.664 to 1.37), Mixed Models Analysis
Prasugrel Healthy Participants vs Prasugrel Sickle Cell Disease: Ratio of Geometric LS Means, SCD:Healthy: 0.612 (90% CI 0.436 to 0.860), Mixed Models Analysis
Prasugrel Healthy Participants vs Prasugrel Sickle Cell Disease: Geometric LS Means, SCD:Healthy: 1.03 (90% CI 0.625 to 1.68), Mixed Models Analysis

13 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prasugrel 10/5 mg Healthy Participants	0 of 4 (0%)	3 of 4 (75%)	Not reported
Prasugrel 10/7.5 mg Healthy Participants	0 of 9 (0%)	5 of 9 (55.6%)	Not reported
All Prasugrel Healthy Participants	0 of 13 (0%)	8 of 13 (61.5%)	Not reported
Prasugrel 10/5 mg Sickle Cell Disease	0 of 4 (0%)	3 of 4 (75%)	Not reported
Prasugrel 10/7.5 mg Sickle Cell Disease	0 of 9 (0%)	7 of 9 (77.8%)	Not reported
All Prasugrel Sickle Cell Disease Participants	0 of 13 (0%)	10 of 13 (76.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Call 1-877-CTLILLY (1-877-285-4559) or 1-317 615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) study director

Eli Lilly and Company

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 Prasugrel in people with Anemia, Sickle Cell, run by Eli Lilly and Company at 1 site in United Kingdom.

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 6 inclusion and 24 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 15 Feb 2012. 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 United Kingdom. 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?

Yes. Results are posted in the registry (first posted 15 Feb 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Area Under the Plasma Concentration-Time Curve (AUC) From Time of Dosing Through the Sampling Time of the Last Quantifiable Concentration [AUC(0-tlast)] for Prasugrel's Active Metabolite, R-138727 (time frame: Time of dosing up to 8 hours post-dose on Day 1 and Day 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01178099.

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 15 Feb 2012; AzTrials last refreshed its copy on 8 Nov 2026.