November 16, 2006Blood

Single and Multiple Oral Doses of AKR-501 (YM477) Increase the Platelet Count in Healthy Volunteers.

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Why the study?

Does AKR-501 increase platelet counts safely in healthy volunteers?

Population

Healthy volunteers (n=90 across single and multiple dose studies)

Comparison

AKR-501 single oral doses or multiple oral doses vs Placebo

Design

RCT, randomized in a ratio of 2:1

Follow-up

14 days

Authors

RDRobert E. DesjardinsResearch Triangle Park Foundation DTDonna L. TempelRockefeller University RLRudolph Lucek

Discussion

Member takes

Implication

Supports phase 2 evaluation in thrombocytopenic patients; extends RCT evidence for oral TPO receptor agonism.

Structured PICO

Does AKR-501 increase platelet counts safely in healthy volunteers?

Population

Healthy volunteers (n=90 across single and multiple dose studies)

Intervention

AKR-501 (YM477) single oral doses (1, 3, 10, 20, 50, 75, 100 mg) or multiple oral doses (3, 10, 20 mg/day for up to 14 days)

Comparator

Placebo

Outcome

Safety, pharmacokinetics, and pharmacodynamic activity (peripheral blood platelet counts, with protocol defined endpoint of >50% increase over baseline)surrogate

AKR-501, an oral TPO receptor agonist, safely and dose-dependently increases platelet counts in healthy volunteers.

Cite This Study

Desjardins et al. (2006) studied this question.

synapsesocial.com/papers/6a8c467acc5fa73295d48eda https://doi.org/10.1182/blood.v108.11.477.477

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November 16, 2006Blood

Single and Multiple Oral Doses of AKR-501 (YM477) Increase the Platelet Count in Healthy Volunteers.

View Full Paper

Ask AI

Bookmark

Why the study?

Does AKR-501 increase platelet counts safely in healthy volunteers?

Population

Healthy volunteers (n=90 across single and multiple dose studies)

Comparison

AKR-501 single oral doses or multiple oral doses vs Placebo

Design

RCT, randomized in a ratio of 2:1

Follow-up

14 days

Authors

RDRobert E. DesjardinsResearch Triangle Park Foundation DTDonna L. TempelRockefeller University RLRudolph Lucek

Discussion

Member takes

Implication

Supports phase 2 evaluation in thrombocytopenic patients; extends RCT evidence for oral TPO receptor agonism.

Structured PICO

Does AKR-501 increase platelet counts safely in healthy volunteers?

Population

Healthy volunteers (n=90 across single and multiple dose studies)

Intervention

AKR-501 (YM477) single oral doses (1, 3, 10, 20, 50, 75, 100 mg) or multiple oral doses (3, 10, 20 mg/day for up to 14 days)

Comparator

Placebo

Outcome

Safety, pharmacokinetics, and pharmacodynamic activity (peripheral blood platelet counts, with protocol defined endpoint of >50% increase over baseline)surrogate

AKR-501, an oral TPO receptor agonist, safely and dose-dependently increases platelet counts in healthy volunteers.

Cite This Study

Desjardins et al. (2006) studied this question.

synapsesocial.com/papers/6a8c467acc5fa73295d48eda https://doi.org/10.1182/blood.v108.11.477.477

Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

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