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Renodapt

Phase 1

Healthy Volunteers | Small molecule | Other |Roche Holding AG|Last Updated: Dec 5, 2016

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment32

FDA Designations

No designations recorded

Clinical trial landscape

Renodapt · 1 trial · 1 indication

Phase 1 1
NCT02981290Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy ParticipantsHealthy Volunteers
COMPLETED32 Analytics
PHASE1COMPLETED
Study to Compare the Pharmacokinetics of Mycophenolate Mofetil Metabolites From Four Tablet Formulations in Healthy Participants
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Study Endpoints

Primary Endpoints

Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0-inf)] of MPA
Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of MPA
Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Maximum Observed Plasma Concentration (Cmax) of MPA
Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Time to Reach Maximum Observed Plasma Concentration (Tmax) of MPA
Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Absorption Lag Time (Tlag) of MPA
Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Plasma Terminal Half-Life (t1/2) of MPA
Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
Apparent Oral Clearance (CL/F) of MPA
Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1

Secondary Endpoints

Apparent Oral Volume of Distribution (V/F) of MPA
Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
AUC (0-inf) of the Glucuronide Metabolite of MPA (MPAG)
Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
AUClast of MPAG
Predose (0.5 hours), and 0.33, 0.66, 1, 1.33, 1.66, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 8, 10, 12, 16, 24, 36, 48 hours post dose on Day 1
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Renodapt Then Mycept Then Cellmune Then CellCeptEXPERIMENTALParticipants will receive Renodapt in first treatment period (each treatment period= 3 days) followed by Mycept in second treatment period then Cellmune in third treatment period and CellCept in fourth treatment period. A washout period of 7 days will be separating each treatment period.
Mycept Then CellCept Then Renodapt Then CellmuneEXPERIMENTALParticipants will receive Mycept in first treatment period (each treatment period= 3 days) followed by CellCept in second treatment period then Renodapt in third treatment period and Cellmune in fourth treatment period. A washout period of 7 days will be separating each treatment period.
Cellmune Then Renodapt Then CellCept Then MyceptEXPERIMENTALParticipants will receive Cellmune in first treatment period (each treatment period= 3 days) followed by Renodapt in second treatment period then CellCept in third treatment period and Mycept in fourth treatment period. A washout period of 7 days will be separating each treatment period.
CellCept Then Cellmune Then Mycept Then RenodaptEXPERIMENTALParticipants will receive CellCept in first treatment period (each treatment period= 3 days) followed by Cellmune in second treatment period then Mycept in third treatment period and Renodapt in fourth treatment period. A washout period of 7 days will be separating each treatment period.

Interventions

NameTypeDescription
RenodaptDRUGRenodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.
MyceptDRUGMycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
CellmuneDRUGCellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
CellCeptDRUGCellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
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Eligibility Criteria

Age Range18 Years to 55 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: A body mass index (BMI) between 18 and 32 kilogram per meter square (kg/m\^2) Exclusion Criteria: * Any evidence of clinically significant allergic, renal, cardiac, bronchopulmonary, vascular, gastro-intestinal, neurological, metabolic or immunodeficiency disorders, cancer, he...

Countries:New Zealand
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Frequently asked questions about Renodapt

What is Renodapt?

Renodapt is an investigational small molecule being developed by Roche Holding AG (RHHBY). It is currently in Phase 1 clinical development. The drug is being studied in healthy volunteers, and its therapeutic area is classified as Other.

What is Renodapt used for?

Renodapt is being studied for use in healthy volunteers. It is currently in Phase 1 clinical development, and the specific indication is not yet established. The drug is being evaluated for its safety and pharmacokinetics in early-stage trials.

Who makes Renodapt?

Renodapt is being developed by Roche Holding AG, a multinational healthcare company. The company's stock is traded under the ticker symbol RHHBY. Roche is conducting clinical trials to evaluate the drug's safety and pharmacokinetics in healthy volunteers.

What phase is Renodapt in?

Renodapt is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The drug is being studied in healthy volunteers to assess its safety and pharmacokinetics.

What clinical trials is Renodapt in?

Renodapt has one completed Phase 1 clinical trial, NCT02981290. This study compared the pharmacokinetics of mycophenolate mofetil metabolites from four tablet formulations in healthy participants. The trial enrolled 32 male participants in New Zealand and was controlled but not double-blinded.

Is Renodapt the same as mycophenolate mofetil?

Renodapt is not the same as mycophenolate mofetil. However, a clinical trial of Renodapt, NCT02981290, studied the pharmacokinetics of mycophenolate mofetil metabolites from four tablet formulations. This suggests Renodapt may be a formulation or prodrug related to mycophenolate mofetil, but the exact relationship is not specified.