A phase 1, randomized, double-blind, placebo-controlled, ascending dose study evaluating the safety, tolerability and pharmacokinetics of JTK-652 administered for two weeks in healthy male subjects

A phase 1, randomized, double-blind, placebo-controlled, ascending dose study evaluating the safety, tolerability and pharmacokinetics of JTK-652 administered for two weeks in healthy male subjects - JTK-652 multiple ascending dose study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON31189

Enrollment

Registered

2007-09-11

Start date

2007-10-15

Completion date

Unknown

Last updated

2024-05-13

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

Conditions

Hepatitis

Interventions

Cohort 1 : three times daily (t.i.d.) an oral dose of 400 mg JTK-652 or placebo on Days 1-13 with a final dose on Day 14. Cohort 2 : t.i.d. an oral dose of 800 mg JTK-652 or placebo on Days 1-13 with

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Man Age : 18-55 yr BMI : 19-28 kg/m2, inclusive

Exclusion criteria

Exclusion criteria: Current abuse of alcohol or/and drugs Clinical significant indications in man's medical history

Design outcomes

Primary

Measure	Time frame
Safety : AE's, clinical laboratory parameters, vital signs, ECG and physical examination Pharmacokinetics : plasma JTK-652 concentrations, pharmacokinetics parameters	—

Secondary

Measure	Time frame
Nvt	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)