Trial Outcomes & Findings for Safety and PK Study of MP-424 to Treat Chronic Hepatitis C (NCT NCT00591214)

NCT ID: NCT00591214

Last Updated: 2026-01-06

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 10 participants
• Primary outcome timeframe: Date were collected at Day1 to Day85
• Results posted on: 2026-01-06

Participant Flow

Participant milestones

Measure	MP-424 Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Overall Study STARTED	10
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Measure	MP-424 Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Overall Study Physician Decision	7
Overall Study Withdrawal by Subject	1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	MP-424 n=10 Participants Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Age, Continuous	54 years STANDARD_DEVIATION 10.2 • n=37 Participants
Sex: Female, Male Female	3 Participants n=37 Participants
Sex: Female, Male Male	7 Participants n=37 Participants

PRIMARY outcome

Timeframe: Date were collected at Day1 to Day85

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.

Outcome measures

Measure	MP-424 n=10 Participants Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Cmax (Maximum Observed Concentration in Plasma) of MP-424 Day 1 (10 cases)	2.24 μg / mL Standard Deviation 0.93
Cmax (Maximum Observed Concentration in Plasma) of MP-424 Day 14 (10 cases)	3.34 μg / mL Standard Deviation 1.11
Cmax (Maximum Observed Concentration in Plasma) of MP-424 Day 85 (3 cases)	3.68 μg / mL Standard Deviation 1.29

PRIMARY outcome

Timeframe: Date were collected at Day1 to Day85

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.

Outcome measures

Measure	MP-424 n=10 Participants Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Tmax (Time of Maximum Plasma Concentration) of MP-424 Day 1 (10 cases)	2.50 hours Interval 2.3 to 7.92
Tmax (Time of Maximum Plasma Concentration) of MP-424 Day 14 (10 cases)	2.49 hours Interval 0.98 to 5.97
Tmax (Time of Maximum Plasma Concentration) of MP-424 Day 85 (3 cases)	2.72 hours Interval 2.68 to 4.0

PRIMARY outcome

Timeframe: Date were collected at Day1 to Day85

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.

Outcome measures

Measure	MP-424 n=10 Participants Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424 Day 1 (10 cases)	11.60 μg x h /mL Standard Deviation 4.74
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424 Day 14 (10 cases)	22.31 μg x h /mL Standard Deviation 8.29
AUC 0-8h (Area Under the Concentration-time Curve From Time Zero to 8 Hours) of MP-424 Day 85 (3 cases)	23.98 μg x h /mL Standard Deviation 9.45

PRIMARY outcome

Timeframe: Date were collected at Day1 to Day85

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.

Outcome measures

Measure	MP-424 n=10 Participants Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Ctrough (Plasma Trough Concentration) of MP-424 Day1 (10 cases)	1.462 μg/mL Standard Deviation 0.949
Ctrough (Plasma Trough Concentration) of MP-424 Day 14 (10 cases)	2.239 μg/mL Standard Deviation 0.953
Ctrough (Plasma Trough Concentration) of MP-424 Day 85 (3 cases)	2.312 μg/mL Standard Deviation 1.265

PRIMARY outcome

Timeframe: Date were collected at Day1 to Day85

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.

Outcome measures

Measure	MP-424 n=10 Participants Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
t1/2 (Half Life Period) of MP-424 Day 1 (7 cases)	5.57 hours Standard Deviation 2.67
t1/2 (Half Life Period) of MP-424 Day 14 (8 cases)	9.64 hours Standard Deviation 6.14
t1/2 (Half Life Period) of MP-424 Day 85 (3 cases)	18.35 hours Standard Deviation 22.91

SECONDARY outcome

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

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)).

Outcome measures

Measure	MP-424 n=10 Participants Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Change in HCV RNA Levels of MP-424 Day 1_4h (10 cases)	-0.195 Log IU / mL Standard Deviation 0.207
Change in HCV RNA Levels of MP-424 Day 14 (10 cases)	-4.895 Log IU / mL Standard Deviation 0.675
Change in HCV RNA Levels of MP-424 Day 29 (10 cases)	-4.785 Log IU / mL Standard Deviation 1.203
Change in HCV RNA Levels of MP-424 Day 57 (5 cases)	-4.120 Log IU / mL Standard Deviation 2.086
Change in HCV RNA Levels of MP-424 Day 86 (3 cases)	-3.867 Log IU / mL Standard Deviation 2.363
Change in HCV RNA Levels of MP-424 Day 1_2.5h (9 cases)	0.100 Log IU / mL Standard Deviation 0.217
Change in HCV RNA Levels of MP-424 Day 1_8h (10 cases)	-1.115 Log IU / mL Standard Deviation 0.376
Change in HCV RNA Levels of MP-424 Day 1_16h (10 cases)	-2.435 Log IU / mL Standard Deviation 0.408
Change in HCV RNA Levels of MP-424 Day 2 before dosing (10 cases)	-2.955 Log IU / mL Standard Deviation 0.323
Change in HCV RNA Levels of MP-424 Day 3 (10 cases)	-3.735 Log IU / mL Standard Deviation 0.369
Change in HCV RNA Levels of MP-424 Day 8 (10 cases)	-4.505 Log IU / mL Standard Deviation 0.633
Change in HCV RNA Levels of MP-424 Day 43 (10 cases)	-3.815 Log IU / mL Standard Deviation 1.344

Adverse Events

MP-424

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	MP-424 n=10 participants at risk Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
Infections and infestations Nasopharyngitis	20.0% 2/10
Blood and lymphatic system disorders Anaemia	70.0% 7/10
Metabolism and nutrition disorders Anorexia	10.0% 1/10
Metabolism and nutrition disorders Hyperuricaemia	10.0% 1/10
Nervous system disorders Headache	10.0% 1/10
Ear and labyrinth disorders Vertigo	10.0% 1/10
Respiratory, thoracic and mediastinal disorders Dyspnoea	10.0% 1/10
Gastrointestinal disorders Stomach discomfort	40.0% 4/10
Gastrointestinal disorders Diarrhoea	10.0% 1/10
Gastrointestinal disorders Dyspepsia	10.0% 1/10
Gastrointestinal disorders Abdominal pain upper	10.0% 1/10
Gastrointestinal disorders Constipation	10.0% 1/10
Gastrointestinal disorders Periodontitis	10.0% 1/10
Skin and subcutaneous tissue disorders Rash	80.0% 8/10
Skin and subcutaneous tissue disorders Pruritus	30.0% 3/10
Skin and subcutaneous tissue disorders Rash pruritic	10.0% 1/10
Musculoskeletal and connective tissue disorders Back pain	10.0% 1/10
Musculoskeletal and connective tissue disorders Musculoskeletal pain	10.0% 1/10
General disorders Oedema peripheral	30.0% 3/10
General disorders Pyrexia	20.0% 2/10
General disorders Malaise	20.0% 2/10
General disorders Thirst	10.0% 1/10
Investigations Low density lipoprotein increased	50.0% 5/10
Investigations Blood uric acid increased	50.0% 5/10
Investigations Blood triglycerides increased	30.0% 3/10
Investigations Blood creatinine increased	10.0% 1/10
Investigations Blood lactate dehydrogenase increased	10.0% 1/10
Investigations Blood luteinising hormone increased	10.0% 1/10
Investigations Eosinophil percentage increased	10.0% 1/10
Investigations Lymphocyte percentage decreased	10.0% 1/10
Investigations Blood cholesterol increased	10.0% 1/10
Cardiac disorders Palpitation	10.0% 1/10
Eye disorders Conjunctivitis	10.0% 1/10
Eye disorders Myodesopsia	10.0% 1/10
Gastrointestinal disorders Ginginal swelling	10.0% 1/10
Investigations Blood gonadotropin increased	10.0% 1/10
Investigations Differential white blood cell count abnormal	10.0% 1/10
Nervous system disorders Facial palsy	10.0% 1/10
Respiratory, thoracic and mediastinal disorders Epistaxis	10.0% 1/10

Additional Information

Clinical Trials, Information Desk

Tanabe Pharma Corporation

Email: cti-inq-ml.JP@ml.tanabe-pharma.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: OTHER