A First in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of QCC374

Phase 1

Completed

• Conditions: Healthy Subjects
• Interventions: Drug: QCC374; Drug: Placebo

• Registration Number: NCT02245828
• Lead Sponsor: Novartis Pharmaceuticals

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-28
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-22
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-20
• Last Update Posted: 2016-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1. Written informed consent must be obtained before any assessment is performed.
2. 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.
3. 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.
4. Oxygen saturation (O2) at screening must be ≥ 95% on room air.
5. FEV1 ≥ 90% predicted.

Exclusion Criteria

1. 1. A history of clinically significant ECG abnormalities and/or orthostatic vital signs at screening.
2. History of asthma or reactive airway diseases.
3. Smokers or anyone who smoked within 5 years of screening. Urine cotinine levels ≥ 500 ng/mL.
4. 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.
5. Women of child-bearing potential

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
QCC374	QCC374	Single and multiple ascending doses of QCC374
Placebo	Placebo	Placebo comparator

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	39 days	Number of Participants with Adverse Events

Secondary Outcome Measures

Name	Time	Method
AUCinf	39 days	Area under the plasma concentration-time curve from time zero to infinity
Cav	39 days	The average steady state plasma concentration during multiple dosing
Cmax	39 days	The observed maximum plasma concentration following drug administration
AUClast	39 days	The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration
T1/2	39 days	The terminal elimination half life
Tmax	39 days	The time to reach the maximum concentration after drug administration
AUCtau	39 days	The area under the plasma concentration-time curve from time zero to the end of the dosing interval tau

Trial Locations

Locations (1)

Novartis Investigative Site; 🇬🇧 Mid Glamorgan, Wales, United Kingdom