A Study to Further Understand the Effects of SCH 527123 on Tissue Neutrophils

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12609000661279
• Date of registration: 05/08/2009
• Prospective Registration: No
• Primary sponsor: Schering-Plough
• Public title: A Study to Further Understand the Effects of SCH 527123 on Tissue Neutrophils
• Scientific title: A Study to Further Understand the Effects of SCH 527123 on Tissue Neutrophils in Healthy Adult Volunteers
• Date of first enrolment: 19/07/2009
• Target sample size: 23
• Recruitment status: Recruiting
• URL: https://anzctr.org.au/ACTRN12609000661279.aspx
• Study type: Interventional
• Study design: Purpose: Treatment; Allocation: Randomised controlled trial;

Countries of recruitment

Australia

Contacts

• Name: Dr Peter Hodsman

• Name: Ms Sarah Wilson

Key inclusion & exclusion criteria

Inclusion criteria: Part 1: Healthy adult

Part 2: Healthy adult, free of moderate or severe oral mucosal disease
Exclusion criteria: History of malignancy, subjects who smoke, Human Immunodeficiency Virus (HIV), Hepatitis B, Hepatitis C, Neutrophil count of < 2.5 x 10^9/L

Age minimum: 18 Years
Age maximum: 65 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Other - Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Respiratory - Chronic obstructive pulmonary disease

for Chronic Obstructive Pulmonary Disease(COPD) - the tolerability and safety of 100 mg SCH 527123 in healthy subjects;for Chronic Obstructive Pulmonary Disease(COPD) - the dose-response relationship of effects of SCH 527123 on neutrophils in the oral mucosa in healthy volunteers, as a determinant of neutrophil response while using study drug;
for Chronic Obstructive Pulmonary Disease(COPD) - the tolerability and safety of 100 mg SCH 527123 in healthy subjects
for Chronic Obstructive Pulmonary Disease(COPD) - the dose-response relationship of effects of SCH 527123 on neutrophils in the oral mucosa in healthy volunteers, as a determinant of neutrophil response while using study drug

Intervention(s)

Part 1: SCH 527123 100mg once daily for 14 days, oral

Part 2: SCH 527123 10mg twice daily or 30mg once daily or 100mg once daily for 5 days, oral (each subject receives all 5 treatments [3 with SCH 527123, 1 with placebo (sugar pill), 1 with prednisone] in a randomised sequence, separated by 7 days)

Separate subjects will be used in each part

Primary Outcome(s)

Part 2: To define the dose-response relationship of the effects of SCH 527123 on neutrophils in the oral mucosa. Measured via analysis of oral mucosal neutrophils collected from oral rinses.[Part 2: Assessed on Days 1-9 of each period]

Part 1: To evaluate the safety and tolerability of 100 mg SCH 527123 when administered orally for 14 days to healthy volunteers. Measured via blood analysis, questionnaires, mointoring of electrocardiography (ECG) and vital signs (temperature, blood pressure, pulse)[Part 1: Assessed on Days 1, 2, 3, 5, 7, 10, 13, 17]

Secondary Outcome(s)

Part 1: To characterize multiple dose pharmacokinetic profile of 100 mg SCH 527123 in healthy subjects. Measured via blood analysis.[Part 1: Assessed on Days 1-2 and 11-18]

Part 2: To explore the effect of SCH 527123 100 mg on peripheral blood neutrophils and to explore the effect of dose regimen on peripheral blood neutrophils and neutrophils in the oral mucosa. Measured via blood analysis and analysis of oral mucosal neutrophils collected from oral rinses.[Part 2: Assessed on Days 1-9 of each period]

Source(s) of Monetary Support

Schering-Plough