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Safety and PK Study of MP-424 to Treat Chronic Hepatitis C

A Phase I, Open-Label, Single-Dose Study of MP-424 in Patients With Genotype 1b Hepatitis C

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00591214
Enrollment
10
Registered
2008-01-11
Start date
2007-12-31
Completion date
2008-10-31
Last updated
2026-01-06

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

Conditions

Chronic Hepatitis C

Keywords

Chronic Hepatitis C, Protease Inhibitor

Brief 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.

Interventions

DRUGMP-424 (Telaprevir)

Three tablets of MP-424 250mg tablet at a time, every 8 hours, 12 weeks administration (dose in a day: 2250 mg)

Sponsors

Vertex Pharmaceuticals Incorporated
CollaboratorINDUSTRY
Tanabe Pharma Corporation
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Cmax (Maximum Observed Concentration in Plasma) of MP-424Date were collected at Day1 to Day85Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.
Tmax (Time of Maximum Plasma Concentration) of MP-424Date were collected at Day1 to Day85Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424Date were collected at Day1 to Day85Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.
Ctrough (Plasma Trough Concentration) of MP-424Date were collected at Day1 to Day85Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.
t1/2 (Half Life Period) of MP-424Date were collected at Day1 to Day85Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.

Secondary

MeasureTime frameDescription
Change in HCV RNA Levels of MP-424Day1 (2.5, 4, 8, 16 hours), Day2, Day3, Day8, Day14, Day29, Day43, Day57 and Day86Date were collected at Day -28, Day1 (0 (pre-dose), 2.5, 4, 8, 16 hours post-dose), Day2, Day3, Day8, Day14, Day29, Day43, Day57, Day86. Change Value was calculated as the each time point minus the baseline point which was averaged Day -28 and Day0-0hour(pre-dose)).

Countries

Japan

Participant flow

Participants by arm

ArmCount
MP-424
Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
10
Total10

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyPhysician Decision7
Overall StudyWithdrawal by Subject1

Baseline characteristics

CharacteristicMP-424
Age, Continuous54 years
STANDARD_DEVIATION 10.2
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
9 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424

Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.

Time frame: Date were collected at Day1 to Day85

ArmMeasureGroupValue (MEAN)Dispersion
MP-424AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424Day 1 (10 cases)11.60 μg x h /mLStandard Deviation 4.74
MP-424AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424Day 14 (10 cases)22.31 μg x h /mLStandard Deviation 8.29
MP-424AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424Day 85 (3 cases)23.98 μg x h /mLStandard Deviation 9.45
Primary

Cmax (Maximum Observed Concentration in Plasma) of MP-424

Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.

Time frame: Date were collected at Day1 to Day85

ArmMeasureGroupValue (MEAN)Dispersion
MP-424Cmax (Maximum Observed Concentration in Plasma) of MP-424Day 1 (10 cases)2.24 μg / mLStandard Deviation 0.93
MP-424Cmax (Maximum Observed Concentration in Plasma) of MP-424Day 14 (10 cases)3.34 μg / mLStandard Deviation 1.11
MP-424Cmax (Maximum Observed Concentration in Plasma) of MP-424Day 85 (3 cases)3.68 μg / mLStandard Deviation 1.29
Primary

Ctrough (Plasma Trough Concentration) of MP-424

Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.

Time frame: Date were collected at Day1 to Day85

ArmMeasureGroupValue (MEAN)Dispersion
MP-424Ctrough (Plasma Trough Concentration) of MP-424Day1 (10 cases)1.462 μg/mLStandard Deviation 0.949
MP-424Ctrough (Plasma Trough Concentration) of MP-424Day 14 (10 cases)2.239 μg/mLStandard Deviation 0.953
MP-424Ctrough (Plasma Trough Concentration) of MP-424Day 85 (3 cases)2.312 μg/mLStandard Deviation 1.265
Primary

t1/2 (Half Life Period) of MP-424

Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.

Time frame: Date were collected at Day1 to Day85

ArmMeasureGroupValue (MEAN)Dispersion
MP-424t1/2 (Half Life Period) of MP-424Day 1 (7 cases)5.57 hoursStandard Deviation 2.67
MP-424t1/2 (Half Life Period) of MP-424Day 14 (8 cases)9.64 hoursStandard Deviation 6.14
MP-424t1/2 (Half Life Period) of MP-424Day 85 (3 cases)18.35 hoursStandard Deviation 22.91
Primary

Tmax (Time of Maximum Plasma Concentration) of MP-424

Date were collected at Day1 (0 (pre-dose), 1 ,2.5, 4, 6, 8, 12, 16 hours post-dose), Day14 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16 hours post-dose) and Day85 (0 (pre-dose), 1, 2.5, 4, 6, 8, 12, 16, 24 hours post-dose). Date as pre-dose were collected at Day2, Day3, Day8, Day15, Day29, Day43 and Day57.

Time frame: Date were collected at Day1 to Day85

ArmMeasureGroupValue (MEDIAN)
MP-424Tmax (Time of Maximum Plasma Concentration) of MP-424Day 1 (10 cases)2.50 hours
MP-424Tmax (Time of Maximum Plasma Concentration) of MP-424Day 14 (10 cases)2.49 hours
MP-424Tmax (Time of Maximum Plasma Concentration) of MP-424Day 85 (3 cases)2.72 hours
Secondary

Change in HCV RNA Levels of MP-424

Date were collected at Day -28, Day1 (0 (pre-dose), 2.5, 4, 8, 16 hours post-dose), Day2, Day3, Day8, Day14, Day29, Day43, Day57, Day86. Change Value was calculated as the each time point minus the baseline point which was averaged Day -28 and Day0-0hour(pre-dose)).

Time frame: Day1 (2.5, 4, 8, 16 hours), Day2, Day3, Day8, Day14, Day29, Day43, Day57 and Day86

ArmMeasureGroupValue (MEAN)Dispersion
MP-424Change in HCV RNA Levels of MP-424Day 1_2.5h (9 cases)0.100 Log IU / mLStandard Deviation 0.217
MP-424Change in HCV RNA Levels of MP-424Day 1_4h (10 cases)-0.195 Log IU / mLStandard Deviation 0.207
MP-424Change in HCV RNA Levels of MP-424Day 1_8h (10 cases)-1.115 Log IU / mLStandard Deviation 0.376
MP-424Change in HCV RNA Levels of MP-424Day 1_16h (10 cases)-2.435 Log IU / mLStandard Deviation 0.408
MP-424Change in HCV RNA Levels of MP-424Day 2 before dosing (10 cases)-2.955 Log IU / mLStandard Deviation 0.323
MP-424Change in HCV RNA Levels of MP-424Day 3 (10 cases)-3.735 Log IU / mLStandard Deviation 0.369
MP-424Change in HCV RNA Levels of MP-424Day 8 (10 cases)-4.505 Log IU / mLStandard Deviation 0.633
MP-424Change in HCV RNA Levels of MP-424Day 14 (10 cases)-4.895 Log IU / mLStandard Deviation 0.675
MP-424Change in HCV RNA Levels of MP-424Day 29 (10 cases)-4.785 Log IU / mLStandard Deviation 1.203
MP-424Change in HCV RNA Levels of MP-424Day 43 (10 cases)-3.815 Log IU / mLStandard Deviation 1.344
MP-424Change in HCV RNA Levels of MP-424Day 57 (5 cases)-4.120 Log IU / mLStandard Deviation 2.086
MP-424Change in HCV RNA Levels of MP-424Day 86 (3 cases)-3.867 Log IU / mLStandard Deviation 2.363

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026