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RO5428029

Phase 1

Healthy Volunteer | Small molecule | Other |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

RO5428029 · 2 trials · 2 indications

Phase 1 2
NCT01371162A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis CHepatitis C, Chronic, Healthy Volunteer
COMPLETED42 Analytics
NCT01345942A Study on the Effect of Food on the Pharmacokinetics of RO5428029 in Healthy VolunteersHealthy Volunteer
COMPLETED12 Analytics
PHASE1COMPLETED
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
Hepatitis C, Chronic, Healthy Volunteer
NCT0137116242
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PHASE1COMPLETED
A Study on the Effect of Food on the Pharmacokinetics of RO5428029 in Healthy Volunteers
Healthy Volunteer
NCT0134594212
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Study Endpoints

Primary Endpoints

Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)
up to 17 days
Parts A + B: Safety: Incidence of adverse events
up to 24 days
Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)
up to 24 days
Effect of food on pharmacokinetics (plasma concentrations) of RO5428029 following oral administration
72 hours

Secondary Endpoints

Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test
up to 17 days
Safety: Incidence of adverse events
approximately 3 weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
A1 Healthy VolunteersEXPERIMENTAL -
A2PLACEBO_COMPARATOR -
B1 HCV InfectionEXPERIMENTAL -
B2PLACEBO_COMPARATOR -
A foodEXPERIMENTAL -
B without foodEXPERIMENTAL -

Interventions

NameTypeDescription
RO5428029DRUGMultiple ascending doses
placeboDRUGmultiple doses
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites6

Inclusion Criteria: * Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive * Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg * Female subjects/patients must be surgically sterile or post-menopausa...

Countries:FranceNetherlandsPolandUnited States
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Frequently asked questions about RO5428029

What is RO5428029 used for?

RO5428029 is an investigational small molecule being studied for the treatment of chronic Hepatitis C, as well as in healthy volunteers for pharmacokinetic studies. It is being developed by Roche Holding AG and is currently in Phase 1 clinical development.

Who makes RO5428029?

RO5428029 is being developed by Roche Holding AG, a multinational healthcare company. The company's stock is traded under the ticker symbol RHHBY on the OTC market.

What phase is RO5428029 in?

RO5428029 is in Phase 1 clinical development. It has completed two Phase 1 trials, one studying the effect of food on its pharmacokinetics in healthy volunteers and another in healthy volunteers and patients with chronic Hepatitis C.

What clinical trials is RO5428029 in?

RO5428029 has been studied in two completed Phase 1 clinical trials: NCT01345942, which evaluated the effect of food on its pharmacokinetics in healthy volunteers, and NCT01371162, which studied the drug in healthy volunteers and patients with chronic Hepatitis C.

Is RO5428029 FDA approved?

RO5428029 is not FDA approved. It is an investigational drug that has completed Phase 1 clinical trials, but it remains in clinical development and has not been approved for any use.