A randomized, open-label, 4-group, 2-period replicate design study to evaluate within- and between-subject variability in exposure of two lots of E5501 20 mg tablets administered as single doses of 40 mg, in the fasted and fed conditions to healthy subjects.

A randomized, open-label, 4-group, 2-period replicate design study to evaluate within- and between-subject variability in exposure of two lots of E5501 20 mg tablets administered as single doses of 40 mg, in the fasted and fed conditions to healthy subjects. - E5501 BA and FE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36548

Enrollment

Registered

2011-01-25

Start date

2011-02-28

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

low blood platelet number Thrombocytopenia

Interventions

Study Medication Active substance : E5501 Activity : c-Mpl agonist Indication: adult chronic immune thrombocytopenic purpura (ITP), thrombocytopenia associated with chronic liver disease (TLD) and p

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Age : 18-55 yrs, inclusive BMI : 18-32 kg/m2, inclusive Blood platelet count: *120 x 10E9/L and *250 x 10E9/L Roken: non- or light smokers

Exclusion criteria

Exclusion criteria: 1) Evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact the PK of study drug 2) Agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of first study drug administration 3) Evidence of organ dysfunction or any clinically significant deviation from normal in their medical history, e.g., history of splenectomy 4) History of venous or arterial thrombotic disease or other hypercoaguable state 5) Hemoglobin less than lower limit of normal (LLN) levels (females 7.1 mmol/L, males 8.1 mmol/L)

Design outcomes

Secondary

Measure	Time frame
Not applicable.	—

Primary

Measure	Time frame
Criteria for evaluation Pharmacokinetics: plasma E5501 concentrations, pharmacokinetic parameters Safety : adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)