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standardized turmeric root extract

Phase 1

Cystic Fibrosis | Small molecule | Respiratory |Seer, Inc.|Last Updated: Dec 25, 2007

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment11
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00219882Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic FibrosisPHASE1 COMPLETED 11Apr 1, 2005Jan 1, 2006Dec 25, 20072 United States
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Study Endpoints
Primary Endpoints
Safety and tolerability of 14 days of treatment with orally administered curcuminoids as assessed by adverse events, laboratory parameters, and spirometry.
14 days
Secondary Endpoints
(1) Pharmacokinetics of repeated doses of orally administered curcuminoids. (2) Change in nasal potential difference (NPD) measurements. (3) Change in sweat chloride measurements.
14 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALstandardized turmeric root extract
Interventions
NameTypeDescription
standardized turmeric root extractDRUG1.5 gm of standardized tumeric root extract three times per day for seven consecutive days, followed by 3 gm of standardized tumeric root extract three times per day for seven consecutive days
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male or female 18 - 40 years of age. * Documented history of being homozygous for ΔF508 CFTR genotype. * Able to perform spirometry maneuvers, and have a forced expiratory volume at 1 second (FEV1) greater than or equal to 30% of predicted normal for age, gender, and height (K...

Countries:United States
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