A First in Human, Single-dose Escalation Study of LY2562175 In Healthy Subjects

A First in Human, Single-dose Escalation Study of LY2562175 In Healthy Subjects - LY2562175 single dose escalation study in humans

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON33901

Enrollment

Registered

2009-03-18

Start date

2009-03-23

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

lipids metabolism

Interventions

Study medication Active substance: LY2562175 Activity : potent farnesoid x receptor agonist Indication : dyslipidemia Strength : 5, 25 and 100 mg Dosage form: capsules Treatments Group 1 period 1: a

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy men or women of non child bearing potential 18 - 60 years inclusive

Exclusion criteria

Exclusion criteria: 18 - 60 years inclusive BMI 18 - 30 kg/m By screening no abnormalities found

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics: plasma LY2562175 concentrations, pharmacokinetic parameters Safety: adverse events, vital signs, ECG-parameters, laboratory parameters, physical examination	—

Secondary

Measure	Time frame
Pharmacodynamics : bile acid panel, fasting lipid panel (TG, LDL-C, VLDL-C, directed HDL, HDL-C and TC) and target engagement as measured by changes in TG, LDL-C and HDL-C.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)