Recent Updates
Recently added Catalysts

MK0633

Phase 1

Asthma | Small molecule | Respiratory |Merck & Company, Inc.|Last Updated: Jul 3, 2015

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
Premium
Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedUNCONTROLLEDBiomarker
Total Trials3
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00768170MK0633 Single Dose Study in Japanese Asthmatic Children Aged 12 to Less Than 16 Years (0633-028)PHASE1 COMPLETED 10Sep 1, 2008May 1, 2009Jul 3, 2015 -
NCT00751413Plasma Levels of MK0633 in Children Ages 6-12 (0633-023)PHASE1 COMPLETED 22Aug 1, 2008Jan 1, 2009Jun 1, 2015 -
NCT00646789A Study to Evaluate the Safety, Tolerability and Plasma Concentration Profiles of MK0633 in Asthmatic Children Aged 12 to Less Than 16 Years (0633-019)PHASE1 COMPLETED 12May 1, 2008Jul 1, 2008Jun 1, 2015 -
Unlock Drug Trial Details
Study Endpoints
Primary Endpoints
To evaluate the safety and tolerability of MK0633 in adolescent asthma patients based on any clinical or laboratory adverse experiences
1 day
To evaluate the safety and tolerability of single oral doses of MK0633 in pediatric asthma patients.
Physical examinations, vital sign measurements, laboratory safety tests (blood chemistry, hematology and urinalysis), urine ß-hCG test, and 12-lead ECGs will be performed at various scheduled time points throughout the study.
To evaluate the safety and tolerability of MK0633 in adolescent asthma patients.
Blood and urine samples will be collected at specified intervals for 72 hours after study drug administration.
Secondary Endpoints
To obtain information on plasma pharmacokinetics (e.g., AUC0-inf, Cmax, Tmax, apparent t½,) of MK0633 after a single oral dose administration in pediatric asthma patients
Plasma will be analyzed at specific time-points for MK0633 concentrations. Urine will be collected for the measurement of LTE4 concentration.
Unlock Study Endpoints
Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMK0633
Interventions
NameTypeDescription
MK0633DRUGMK0633 (50 mg) Oral, single dose
Comparator: MK0633DRUGA single dose of MK0633 10 mg or 25 mg film coated tablet. Dose will be based on patient weight.
Unlock Study Design Details
Eligibility Criteria
Age Range12 Years — 15 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Patient Is Judged To Be In Good Health, Other Than Having Mild To Moderate Asthma, Based On Medical History, Physical Examination, Vital Signs, And Laboratory Safety Tests * Patient Has No Clinically Significant Abnormality On Electrocardiogram (Ecg) Performed At The Prestudy ...

Unlock Eligibility Criteria