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

Healthy Subjects Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02245828
• Other study ID #: CQCC374X2101
• Status: Completed
• Phase: Phase 1
• First received: August 28, 2014
• Last updated: March 20, 2016
• Start date: July 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy Subjects

Intervention

Drug:
• QCC374
Single and multiple ascending doses of QCC374
• Placebo
Placebo comparator

Locations

Country	Name	City	State
United Kingdom	Novartis Investigative Site	Mid Glamorgan	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and tolerability	Number of Participants with Adverse Events	39 days	Yes
Secondary	AUCinf	Area under the plasma concentration-time curve from time zero to infinity	39 days	No
Secondary	AUClast	The area under the plasma concentration-time curve from time zero to the time of the last quantifiable concentration	39 days	No
Secondary	AUCtau	The area under the plasma concentration-time curve from time zero to the end of the dosing interval tau	39 days	No
Secondary	Cav	The average steady state plasma concentration during multiple dosing	39 days	No
Secondary	Cmax	The observed maximum plasma concentration following drug administration	39 days	No
Secondary	T1/2	The terminal elimination half life	39 days	No
Secondary	Tmax	The time to reach the maximum concentration after drug administration	39 days	No