A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ALTERNATING PANEL, SINGLE ASCENDING DOSE STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF JTK-656 AND THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF JTK-656 IN HEALTHY MALE SUBJECTS

A PHASE 1, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ALTERNATING PANEL, SINGLE ASCENDING DOSE STUDY EVALUATING THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF JTK-656 AND THE EFFECT OF FOOD ON THE PHARMACOKINETICS OF JTK-656 IN HEALTHY MALE SUBJECTS - JTK-656 single ascending dose and food effect study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON32420

Enrollment

Registered

2008-06-24

Start date

2008-08-01

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

immune deficiency infections

Interventions

Study Medication Active substance :JTK-656 Activity :HIV integrase inhibitor Indication :HIV-1 infection Strength :0.3 mg/2 g PEG400, 1.5 mg/2 g PEG400 and 7.5 mg/2 g PEG400 (Part 1) and 25 and 200 m

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy volunteers Male 18 and 55 years of age Body Mass Index: 19 - 28 kg/m2, inclusive, at the screening visit

Exclusion criteria

Exclusion criteria: Clinically relevant medical history Hypersensitivity to any component of the JTK-656 formulation

Design outcomes

Primary

Measure	Time frame
Criteria for evaluation Pharmacokinetics :Plasma JTK-656 concentrations, PK parameters Safety :AEs, vital signs, ECG-parameters, laboratory parameters, physical examination and weight Exploratory lipid profile assessments :HDL2-cholesterol and HDL3-cholesterol Statistical methods Pharmacokinetic parameters :Analysis of variance (ANOVA) on Cmax and AUC to explore the food effect, statistical analysis on dose-normalized Cmax, AUClast and AUCinf to assess dose proportionality, other parameters descriptive statistics Safety parameters :Descriptive statistics, frequency tables Exploratory lipid profile parameters :Descriptive statistics	—

Measure

Time frame

Criteria for evaluation Pharmacokinetics :Plasma JTK-656 concentrations, PK parameters Safety :AEs, vital signs, ECG-parameters, laboratory parameters, physical examination and weight Exploratory lipid profile assessments :HDL2-cholesterol and HDL3-cholesterol Statistical methods Pharmacokinetic parameters :Analysis of variance (ANOVA) on Cmax and AUC to explore the food effect, statistical analysis on dose-normalized Cmax, AUClast and AUCinf to assess dose proportionality, other parameters descriptive statistics Safety parameters :Descriptive statistics, frequency tables Exploratory lipid profile parameters :Descriptive statistics

—

Secondary

Measure	Time frame
N.v.t.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)