TMC435-TiDP16-C113: A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics of TMC435
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ClinicalTrials.gov Identifier: NCT01046058 |
Recruitment Status
:
Completed
First Posted
: January 11, 2010
Last Update Posted
: October 14, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hepatitis C Virus | Drug: TMC435 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 23 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase I, Open-label, Sequential Trial to Investigate the Pharmacokinetics, Safety, and Tolerability of TMC435 in Subjects With Moderately or Severely Impaired Hepatic Function |
Study Start Date : | January 2010 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Panel A: TMC435 150 mg
Participants enrolled in Panel A had moderate hepatic failure and received TMC435 150 mg once daily for 7 days.
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Drug: TMC435
150 mg (two 75-mg capsules) orally (by mouth) once daily for 7 days
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Experimental: Panel B: TMC435 150 mg
Participants enrolled in Panel B had severe hepatic impairment and received TMC435 150 mg once daily for 7 days after the safety of TMC435 150 mg once daily for 7 days was evaluated in participants enrolled in Panel A.
|
Drug: TMC435
150 mg (two 75-mg capsules) orally (by mouth) once daily for 7 days
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- Pharmacokinetic profile of TMC435 in patients with moderate and severe hepatic impairment [ Time Frame: Measured at 16 predefined time points over a period of 9 days. Extensive analysis is planned on Day7 (after last intake of TMC435), with 12 PK sampling moments over 48 hours. ]
- Short-term safety and tolerability of TMC435 in volunteers with moderate or severe hepatic impairment [ Time Frame: AEs monitored each visit; vital signs, urinalysis and ECG parameters on Day 7 and on both follow-up visits; Safety blood sample at 6 predefined timepoints (over 5 days) and on both follow-up visits. ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Participants with hepatic impairment: Moderate or severe hepatic impairment, clinically diagnosed as Child Pugh B or C
- Stable liver cirrhosis and hepatic impairment for at least 3 months prior to the start of the study. Participants with normal hepatic function: Healthy based on a medical evaluation including medical history, physical examination, blood tests and electrocardiogram
Exclusion Criteria:
- Participants with hepatic impairment: Fluctuating or rapidly deteriorating hepatic function as indicated by widely varying or worsening of clinical and/or laboratory signs of hepatic impairment within 3 months prior or within the screening period
- Cirrhosis due to chronic hepatitis B or C infection. Participants with normal hepatic function: History or presence of hepatic disease

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01046058
United States, California | |
Anaheim, California, United States | |
United States, Florida | |
Orlando, Florida, United States | |
United States, Texas | |
San Antonio, Texas, United States |
Study Director: | Tibotec Pharmaceuticals Clinical Trial | Tibotec Pharmaceutical Limited |
Additional Information:
Responsible Party: | Tibotec Pharmaceuticals, Ireland |
ClinicalTrials.gov Identifier: | NCT01046058 History of Changes |
Other Study ID Numbers: |
CR016783 TMC435-TiDP16-C113 ( Other Identifier: Tibotec Pharmaceuticals, Ireland ) |
First Posted: | January 11, 2010 Key Record Dates |
Last Update Posted: | October 14, 2013 |
Last Verified: | October 2013 |
Keywords provided by Tibotec Pharmaceuticals, Ireland:
TMC435-TiDP16-C113 TMC435-C113 TMC435 |
HCV Protease Inhibitor Hepatitis C |
Additional relevant MeSH terms:
Hepatitis Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections |
RNA Virus Infections Simeprevir Antiviral Agents Anti-Infective Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |