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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Subjects
• Intervention / Treatment: Drug: Placebo; Drug: QCC374

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Wales
    • Mid Glamorgan, Wales, United Kingdom, CF484DR
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo comparator	Drug: Placebo; Placebo comparator
Experimental: QCC374; Single and multiple ascending doses of QCC374	Drug: QCC374; Single and multiple ascending doses of QCC374

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and tolerability	Number of Participants with Adverse Events	39 days

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 28, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 22, 2014

Study Record Updates

• Last Update Posted (Estimate): March 22, 2016
• Last Update Submitted That Met QC Criteria: March 20, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: healthy subjects, inhaled
• Other Study ID Numbers: CQCC374X2101