Phase I, double blind, randomized, placebo-controlled trial in healthy subjects to examine the safety, tolerability and pharmacokinetics of increasing oral doses of TMC435350 after single and repeated dosing, followed by an open label repeated dosing session in 6 HCV-genotype 1 infected patients (non placebo-controlled).

Phase I, double blind, randomized, placebo-controlled trial in healthy subjects to examine the safety, tolerability and pharmacokinetics of increasing oral doses of TMC435350 after single and repeated dosing, followed by an open label repeated dosing session in 6 HCV-genotype 1 infected patients (non placebo-controlled). - TMC435350, SRD and MRD study (FIH)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON30518

Enrollment

Registered

2007-01-08

Start date

2007-02-03

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

hepatitis-C infections

Interventions

See comments at the Dutch section

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Healthy subjects aged between 18 and 55 years. Non-smokers for at least 3 months prior to selection Normal weight as defined by a BMI of 18.0 to 30.0 kg/m2. Normal 12-lead ECG Patients: Subjects aged between 18 and 70 years, extremes included Able to comply with protocol requirements and having good accessible veins. Subjects with chronic Genotype 1 HCV infection, non-responders to previous treatment regimens (being interferon/ ribavirin or pegylated interferon/ribavirin)

Exclusion criteria

Exclusion criteria: Past history of heart arrhythmias or having baseline prolongation of QTc interval > 450 ms, history of risk factors for Torsade de Pointes syndrome or evidence of cardiomyopathy as evidenced by a grade 1 or higher decrease in EF/SF. Female, except if postmenopausal since more than 2 years, or post-hysterectomy, or post tubal ligation. Confirmed Hepatitis A, B, or C infection, or cancer or HIV/AIDS. Participation in an investigational drug trial within 30 days prior to the first intake of trial medication. Donation of blood or plasma within 60 days preceding the first intake of trial medication. Patients: Subjects co-infected with HIV-1, HIV-2 or any hepatitis infection other than HCV. Male subjects with female partners of childbearing potential not agreeing to use a reliable birth control method for 90 days after the last dosing in the study. Subjects on non stable methadone use, on non stable anti-hypertensive treatment or on non stable antidepressant treatment.

Design outcomes

Primary

Measure	Time frame
See comments at the Dutch section	—

Secondary

Measure	Time frame
See comments at the Dutch section	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)