MK-8237 6 DU
BiologicalOther names: SCH 900237
NCT Number: NCT01678807
The purpose of this study is to evaluate the safety of two doses (6 Development Units [DU] and 12 DU) of MK-8237 sublingual tablets compared to Placebo in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis. The primary hypothesis is that at least one dose of MK-8237 sublingual tablet is safe and well-tolerated in adolescents with house dust mite-induced allergic rhinitis/rhinoconjunctivitis.
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Notify Me12 year–17 year
All sexes
Interventional
Phase 1
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Other names: SCH 900237
Other names: SCH 900237
Time frame: From first dose to last dose of treatment plus 2 weeks of follow-up, up to 42 days
An AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol-specified procedure, whether or not considered related to the medicinal product/protocol-specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE. A serious adverse event (SAE) was an AE that resulted in death, was life threatening, resulted in persistent or significant disability/incapacity, resulted in or prolonged an existing inpatient hospitalization, was a congenital anomaly/birth defect, was a cancer, was associated with an overdose, was another important medical event.
Time frame: From first dose to last dose of treatment, up to 28 days
The percentage of participants who had study treatment stopped due to an AE. Discontinuations were reported for all randomized participants who received ≥1 dose of study treatment.
ALK-Abelló A/S
Industry
Safety Study of MK-8237 Treatment in House-Dust-Mite Allergic Adolescents (Protocol 008)
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