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Rifampicin

Phase 1

Solid Tumours | Small molecule | Oncology |AstraZeneca PLC|Last Updated: Jan 16, 2017

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment32
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01929603Study to Assess the Effect of Rifampicin (CYP Inducer) on Blood Levels and Safety of Olaparib in Patients With Advanced Solid TumoursPHASE1 COMPLETED 32 — — Dec 1, 2013Nov 1, 2016Jan 16, 20175 Belgium, Netherlands
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Study Endpoints
Primary Endpoints
Pharmacokinetics of olaparib by assessment of maximum plasma olaparib concentration (Cmax)
Blood samples are collected on olaparib dosing days (Day 1 and 14) at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post olaparib dose Part A.

Rate and extent of absorption of olaparib following single oral doses of olaparib tablet formulation by assessment of maximum plasma olaparib concentration (Cmax). Olaparib doses are first without, then with rifampicin.

Pharmacokinetics of olaparib by assessment of area under the plasma concentration time curve from zero to infinity (AUC)
Blood samples are collected on olaparib dosing days (Day 1 and 14) at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post olaparib dose Part A.

Rate and extent of absorption of olaparib following single oral doses of olaparib tablet formulation by assessment of area under the plasma concentration time curve from zero to infinity (AUC). Olaparib doses are first without, then with rifampicin.

Pharmacokinetics of olaparib by assessment of area under the plasma concentration time curve from zero to the last measurable time point, AUC0-t, if AUC is not adequately estimable.
Blood samples are collected on olaparib dosing days (Day 1 and 14) at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post olaparib dose Part A.

Rate and extent of absorption of olaparib following single oral doses of olaparib tablet formulation by assessment of area under the plasma concentration time curve from zero to the last measurable time point, AUC0-t, if AUC is not adequately estimable. Olaparib doses are first without, then with rifampicin.

Secondary Endpoints
Pharmacokinetics of olaparib by assessment of time to reach maximum plasma concentration for olaparib (tmax).
Blood samples are collected on olaparib dosing days (Day 1 and 14) at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post olaparib dose Part A.
Pharmacokinetics of olaparib by assessment of olaparib area under the plasma concentration time curve from zero to the last measurable time point (AUC0-τ).
Blood samples are collected on olaparib dosing days (Day 1 and 14) at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post olaparib dose Part A.
Pharmacokinetics of olaparib by assessment of olaparib apparent clearance (CL/F).
Blood samples are collected on olaparib dosing days (Day 1 and 14) at pre-dose, 0.25 , 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48, and 72 hours post olaparib dose Part A.
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
Treatment Arms
ArmTypeDescription
Olaparib alone, olaparib+rifampicinEXPERIMENTALSequential treatments of olaparib alone followed by olaparib+rifampicin, with a washout period inbetween.
Interventions
NameTypeDescription
Pharmacokinetic samplingPROCEDUREBlood sampling to measure olaparib, rifampicin and 4β-hydroxycholesterol
RifampicinDRUGRifampicin (CYP inducer) 600mg taken once daily from Day 5 to Day 14 (Part A)
Olaparib tablet dosingDRUGOlaparib 300mg tablet taken on Days 1 and 14 (Part A). Part B dosing is 300mg olaparib bi-daily
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria:- For inclusion in the study, patients should fulfil the following criteria: 1. Provision of written informed consent prior to any study-specific procedures. 2. Patients aged greater than or equal to 18 years. 3. Histologically or, where appropriate, cytologically confirmed mali...

Countries:BelgiumNetherlands
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