Title
Determining the Effect of Actimmune (Interferon Gamma 1b)Dose Titration on Flu-Like Symptoms in Healthy Volunteers
A Randomized, Double-Blind, Crossover Study to Determine the Effect of Actimmune® Dose Titration on the Severity and Incidence of Interferon Gamma-1b-Related Flu-Like Symptoms and the Pattern of Dropouts in Healthy Volunteers
Phase
Phase 1Lead Sponsor
Vidara TherapeuticsStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Adverse Effects in the Therapeutic Use of InterferonIntervention/Treatment
interferon gamma-1b ...Study Participants
40The most frequent side effects associated with Actimmune (interferon gamma 1b) therapy are the occurrence of 'flu-like symptoms' (FLS),which might include fever, chills, muscle aches, and tiredness. Earlier studies have demonstrated that these symptoms are common in healthy volunteers as well as in patients.
This study is designed to determine whether a titration of dosing reduces the frequency and severity of the FLS. A reported study with another interferon (interferon beta), demonstrated a reduction in the frequency and severity of the FLS when a titration of dosing was used. This study will compare the effects of the standard dose regimen with a titration regimen in healthy volunteers.
Standard therapy vs dose titration
Subjects > 0.5m2 BSA will receive 50 mcg/m2 BSA and subjects ≤ 0.5m2 BSA will receive 1.5mcg/kg/dose, as SC injections three times weekly, from week 1 to week 3.
30% of the recommended dose as SC injections three times weekly in week 1, 60% the recommended dose as SC injections three times weekly in week 2, and at the recommended dose as SC injections three times weekly in week 3
Inclusion Criteria: Healthy volunteers Ability to understand purpose & risks BMI 18-32kg/m2 Females on contraception Exclusion Criteria: History of HIV,or pos test for HCV Ab,or HBsAg History of chronic fatigue syndrome or fibromyalgia Flu like illness within 1 month of start History of depression or other mood disorder History of malignant or pre-malignant disease History of severe allergic reactions Known allergy to Actimmune or its components History of major diseases Clinically Significant abnormal labs Pregnant or breastfeeding Clinically abnormal ECG History of alcohol or substance abuse Other study participation in last 4 weeks Serious infection within 3 months Use of Rx products within 4 weeks except contraceptives or dermatology products Vaccinations within 2 weeks Tobacco products ( with limitations) Cant/wont comply with study requirements Allergy shots within 1 month Blood donation with limitations Investigator discretion as to unsuitability
