Phase 1
Completed N=10
Safety and PK Study of MP-424 to Treat Chronic Hepatitis C
Chronic Hepatitis C
Source: ClinicalTrials.gov NCT00591214 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Cmax (Maximum Observed Concentration in Plasma) of MP-424 — 2.24; 3.34; 3.68 μg / mL
Summary
The purpose of this study is to assess the safety, pharmacokinetics and HCV(Hepatitis C virus) RNA (Ribonucleic Acid) kinetics after administration of MP-424 to patients with chronic hepatitis C.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cmax (Maximum Observed Concentration in Plasma) of MP-424 |
2.24; 3.34; 3.68 | — |
| PRIMARY Tmax (Time of Maximum Plasma Concentration) of MP-424 |
2.50; 2.49; 2.72 | — |
| PRIMARY AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424 |
11.60; 22.31; 23.98 | — |
| PRIMARY Ctrough (Plasma Trough Concentration) of MP-424 |
1.462; 2.239; 2.312 | — |
| PRIMARY t1/2 (Half Life Period) of MP-424 |
5.57; 9.64; 18.35 | — |
| SECONDARY Change in HCV RNA Levels of MP-424 |
0.100; -0.195; -1.115; -2.435; -2.955; -3.735 | — |
Eligibility Criteria
Inclusion Criteria
- Patients diagnosed with genotype 1b chronic hepatitis C
- Patients naive to the concomitant medications with interferon
Exclusion Criteria
- Patients diagnosed with decompensated cirrhosis
- Patients diagnosed with positive HBs(Hepatitis B virus surface) antigen in the test
Data sourced from ClinicalTrials.gov (NCT00591214). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.