A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374
A Randomized, Double-blind, Placebo-controlled First-in-human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374 in Healthy Subjects
1 other identifier
interventional
66
1 country
1
Brief Summary
This is a double blind, randomized, placebo controlled, single and multiple ascending dose study in healthy subjects. Safety evaluation will include (serious) adverse events, vital signs, body weight and lung function tests. Blood samples for Pharmacokinetics will also be drawn at specified timepoints.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 28, 2014
CompletedFirst Posted
Study publicly available on registry
September 22, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedMarch 22, 2016
March 1, 2016
1.4 years
August 28, 2014
March 20, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety and tolerability
Number of Participants with Adverse Events
39 days
Secondary Outcomes (7)
AUCinf
39 days
AUClast
39 days
AUCtau
39 days
Cav
39 days
Cmax
39 days
- +2 more secondary outcomes
Study Arms (2)
Placebo
PLACEBO COMPARATORPlacebo comparator
QCC374
EXPERIMENTALSingle and multiple ascending doses of QCC374
Interventions
Eligibility Criteria
You may qualify if:
- Written informed consent must be obtained before any assessment is performed.
- Healthy male and female subjects age 18 to 55 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Weight of at least 50 kg and body mass index (BMI) within the range of 18 - 32 kg/m2. BMI = Body weight (kg) / \[Height (m)\]2.
- Oxygen saturation (O2) at screening must be ≥ 95% on room air.
- FEV1 ≥ 90% predicted.
You may not qualify if:
- \. A history of clinically significant ECG abnormalities and/or orthostatic vital signs at screening.
- History of asthma or reactive airway diseases.
- Smokers or anyone who smoked within 5 years of screening. Urine cotinine levels ≥ 500 ng/mL.
- History of malignancy of any organ system other than localized basal cell carcinoma of the skin, treated or untreated within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- Women of child-bearing potential
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Novartis Investigative Site
Mid Glamorgan, Wales, CF484DR, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2014
First Posted
September 22, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
March 22, 2016
Record last verified: 2016-03