Trial from ClinicalTrials.gov

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Trial ID
NCT02392702
Ethics application status
Date submitted
5/03/2015
Date registered
5/03/2015
Date last updated
22/09/2015

Titles & IDs
Public title
Study to Evaluate Safety, Tolerability and PK of C-10355 and C-10358 in Healthy Subjects
Scientific title
A Two-Part Open-Label, Randomized, Sequential, Crossover, Single Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of C-10355 and C-10358 in Healthy Volunteers, With a PK Comparison to Kalydeco®
Secondary ID [1] 0 0
CP656.1001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: drugs - C-10355
Treatment: drugs - C-10358
Treatment: drugs - Kalydeco

Active Comparator: C-10355, 25 mg - single oral dose.

Active Comparator: C-10358, 25 mg - single oral dose.

Active Comparator: C-10355 or C-10358, 75 mg - single oral dose.

Active Comparator: C-10355 or C-10358, 150 mg - single oral dose.

Active Comparator: Kalydeco, 150 mg - single oral dose.

Active Comparator: C-10355 or C-10358, 300 mg - single oral dose.


Treatment: drugs: C-10355


Treatment: drugs: C-10358


Treatment: drugs: Kalydeco


Intervention code [1] 0 0
Treatment: drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants with Adverse Events as a Measure of Safety and Tolerability - adverse events categorized by body system and MedDRA term
Timepoint [1] 0 0
24 hours
Primary outcome [2] 0 0
Pharmacokinetic Profile - Measure exposure of test articles using area under the concentration time curve (AUC), maximum concentration (Cmax), half life (T 1/2)
Timepoint [2] 0 0
96 hours

Eligibility
Key inclusion criteria
- Healthy adults between 18 and 50 years of age, inclusive

- Body weight = 50 kg and BMI within the range of 18 to 30 kg/m2, inclusive, at
screening
Minimum age
18 Years
Maximum age
50 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- History of clinically significant central nervous system (eg, seizures), cardiac,
pulmonary, metabolic, renal (including nephrolithiasis), hepatic, including history of
Gilbert's syndrome or gastrointestinal (GI) conditions

- PR interval = 220 msec or QRS duration = 120 msec or QTcF interval > 450 msec obtained
at screening visit or prior to the first dose of study drug

- Liver function tests greater than the upper limit of normal.

- Positive blood screen for human immunodeficiency virus (HIV antibody), hepatitis B
virus surface antigen, or hepatitis C virus antibody at screening

- Urinalysis positive for greater than trace blood, protein or glucose

- A positive screen for alcohol, drugs of abuse, or tobacco use.

- Inability to comply with food and beverage restrictions during study participation.

- Donation or blood collection or acute loss of blood prior to screening.

Study design
Purpose of the study
Basic Science
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Current
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Concert Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This two-part study will assess, in healthy volunteers, under both fasted and fed conditions,
and in a sequential manner, the safety, tolerability and pharmacokinetics (PK) profile of
single doses of C-10355 and C-10358 and single ascending doses of the selected compound
compared to a single dose of Kalydeco®.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Lana Pilja
Address 0 0
Concert Pharmaceuticals, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries
Contact person responsible for updating information