HealthyPhase 1NCT02392702
Study to Evaluate Safety, Tolerability and PK of C-10355 and C-10358 in Healthy Subjects
A Phase 1 study testing C-10355, C-10358 and Kalydeco in people with Healthy, run by Concert Pharmaceuticals at 1 site in Australia.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- C-10355, C-10358 and Kalydeco
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteAustralia
- Study dates
- Mar 2015to Sep 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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®
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®.
- Conditions
- Healthy
- Being tested
- C-10355, C-10358, Kalydeco
- Keywords
- Subjects, Safety/Efficacy Study, Randomized, Open Label
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-10355Drug
C-10358Drug
KalydecoDrug
| Study group | Role | What they receive |
|---|---|---|
| C-10355, 25 mg | Active comparator | single oral dose. Receives: Drug: C-10355 |
| C-10358, 25 mg | Active comparator | single oral dose. Receives: Drug: C-10358 |
| C-10355 or C-10358, 75 mg | Active comparator | single oral dose. Receives: Drug: C-10355; Drug: C-10358 |
| C-10355 or C-10358, 150 mg | Active comparator | single oral dose. Receives: Drug: C-10355; Drug: C-10358 |
| Kalydeco, 150 mg | Active comparator | single oral dose. Receives: Drug: Kalydeco |
| C-10355 or C-10358, 300 mg | Active comparator | single oral dose. Receives: Drug: C-10355; Drug: C-10358 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
adverse events categorized by body system and MedDRA term
Measured: 24 hours
Pharmacokinetic Profile
Measure exposure of test articles using area under the concentration time curve (AUC), maximum concentration (Cmax), half life (T 1/2)
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Concert Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lana Pilja, Study director, Concert Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392702
- Sponsor's protocol ID
- CP656.1001
- Status last verified
- Sep 2015
- First submitted
- 5 Mar 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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®
- ClinicalTrials.gov ID
- NCT02392702
- Acronym / sponsor ID
- CP656.1001
- Conditions
- Healthy
- Keywords
- Subjects, Safety/Efficacy Study, Randomized, Open Label
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Concert PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 19 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| C-10355, 25 mg | Active comparator | Drug: C-10355single oral dose. |
| C-10358, 25 mg | Active comparator | Drug: C-10358single oral dose. |
| C-10355 or C-10358, 75 mg | Active comparator | Drug: C-10355, Drug: C-10358single oral dose. |
| C-10355 or C-10358, 150 mg | Active comparator | Drug: C-10355, Drug: C-10358single oral dose. |
| Kalydeco, 150 mg | Active comparator | Drug: Kalydecosingle oral dose. |
| C-10355 or C-10358, 300 mg | Active comparator | Drug: C-10355, Drug: C-10358single oral dose. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-10355 | Drug | C-10355 or C-10358, 150 mg, C-10355 or C-10358, 300 mg, C-10355 or C-10358, 75 mg, C-10355, 25 mg |
| C-10358 | Drug | C-10355 or C-10358, 150 mg, C-10355 or C-10358, 300 mg, C-10355 or C-10358, 75 mg, C-10358, 25 mg |
| Kalydeco | Drug | Kalydeco, 150 mg |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 24 hours
adverse events categorized by body system and MedDRA term
Pharmacokinetic Profile
Time frame: 96 hours
Measure exposure of test articles using area under the concentration time curve (AUC), maximum concentration (Cmax), half life (T 1/2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lana Pilja study director
Concert Pharmaceuticals, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing C-10355, C-10358 and Kalydeco in people with Healthy, run by Concert Pharmaceuticals at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.