Cystic FibrosisPhase 1NCT03527095
A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects
A Phase 1 study testing FDL169 in people with Cystic Fibrosis, run by Flatley Discovery Lab LLC at 1 site in United Kingdom.
Trial summary
This is a randomised, cross-over study comprised of 6 periods in healthy subjects.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- FDL169
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Apr 2018to 21 Jun 2018
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male and non-pregnant, non-lactating female subjects
- Aged 18 to 55 years
- Body mass index of 18.0 to 32.0 kg/m2
- Must agree to the use of an adequate method of contraception
Who cannot join
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- History of any drug or alcohol abuse in the past 2 years
- Current smokers and those who have smoked within the last 12 months.
- Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level >1.5 x upper limit of normal at screening
- Abnormal renal function at screening
- Clinically significant abnormal biochemistry, haematology, coagulation profile or urinalysis
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- Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
- History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or GI disease, neurological or psychiatric disorder.
- Subjects with a history of gall stones or abdominal surgery eg cholecystectomy
- Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
- Subjects who are taking, or have taken, any prescribed or over-the-counter drug or herbal remedy (including known inhibitors or inducers of CYP3A4
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Quotient Sciences
Ruddington, Nottingham, NG11 6JS
About this study
Official title: A Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single Doses
This is a randomised, cross-over study comprised of 6 periods in healthy subjects.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.
Read the detailed description
This is a single centre, randomised, cross-over study comprised of 6 periods in healthy males and females.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.
- Conditions
- Cystic Fibrosis
- Being tested
- FDL169
- Keywords
- Cystic Fibrosis
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FDL169Drug
CFTR corrector
| Study group | Role | What they receive |
|---|---|---|
| Regimen A | Experimental | FDL169 200 mg reference tablet Receives: Drug: FDL169 |
| Regimen B | Experimental | FDL169 200 mg testing tablet 1 Receives: Drug: FDL169 |
| Regimen C | Experimental | FDL169 200 mg testing tablet 2 Receives: Drug: FDL169 |
| Regimen D | Experimental | FDL169 200 mg testing tablet 1 or 2 with high fat diet Receives: Drug: FDL169 |
| Regimen E | Experimental | FDL169 200 mg testing tablet 1 or 2, fasted Receives: Drug: FDL169 |
| Regimen F | Experimental | FDL169 200 mg testing tablet 1 or 2, with standard diet Receives: Drug: FDL169 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative bioavailability of FDL169 and its metabolites with different formulations
To determine the relative bioavailability of FDL169 and its metabolites M1 and M3, following different tablet formulations compared to a reference tablet
Measured: 17 weeks
Secondary outcomes (4)
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability of FDL169 and its metabolites M1 and M3 , as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.
Measured: 17 weeks
Pharmacokinetic parameters, Cmax
The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3 , maximal plasma concentration (Cmax)
Measured: 17 weeks
Pharmacokinetic parameters, Tmax
The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; maximal concentration (Tmax)
Measured: 17 weeks
Pharmacokinetic parameters, AUC
The pharmacokinetic parameters of FDL169 and its metabolites M1 and M3; area under the plasma concentration curve (AUC)
Measured: 17 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2018
- Study start5 Apr 2018
- Primary completion21 Jun 2018
- Study completion21 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flatley Discovery Lab LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Ordonez, Study chair, Flatley Discovery Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527095
- Sponsor's protocol ID
- FDL169-2017-06
- Status last verified
- Nov 2018
- First submitted
- 4 May 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single Doses
- ClinicalTrials.gov ID
- NCT03527095
- Acronym / sponsor ID
- FDL169-2017-06
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Flatley Discovery Lab LLCUniversity, hospital or other
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 21 Jun 2018 (actual)
- Study completion
- 21 Jun 2018 (actual)
- First posted
- 16 May 2018 (actual)
- 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 is a randomised, cross-over study comprised of 6 periods in healthy subjects.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.
Detailed description
This is a single centre, randomised, cross-over study comprised of 6 periods in healthy males and females.Subjects will receive Regimens A, B and C in a randomised crossover manner in the fed state, followed by Regimens D, E and F in a randomised crossover manner, in the fasted or fed state, as applicable.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Regimen A | Experimental | Drug: FDL169FDL169 200 mg reference tablet |
| Regimen B | Experimental | Drug: FDL169FDL169 200 mg testing tablet 1 |
| Regimen C | Experimental | Drug: FDL169FDL169 200 mg testing tablet 2 |
| Regimen D | Experimental | Drug: FDL169FDL169 200 mg testing tablet 1 or 2 with high fat diet |
| Regimen E | Experimental | Drug: FDL169FDL169 200 mg testing tablet 1 or 2, fasted |
| Regimen F | Experimental | Drug: FDL169FDL169 200 mg testing tablet 1 or 2, with standard diet |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male and non-pregnant, non-lactating female subjects
- Aged 18 to 55 years
- Body mass index of 18.0 to 32.0 kg/m2
- Must agree to the use of an adequate method of contraception
Key exclusion criteria (11 listed)
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- History of any drug or alcohol abuse in the past 2 years
- Current smokers and those who have smoked within the last 12 months.
- Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level >1.5 x upper limit of normal at screening
- Abnormal renal function at screening
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 |
|---|---|---|
| FDL169CFTR corrector | Drug | Regimen A, Regimen B, Regimen C, Regimen D, Regimen E, Regimen F |
Primary outcome
Relative bioavailability of FDL169 and its metabolites with different formulations
Time frame: 17 weeks
To determine the relative bioavailability of FDL169 and its metabolites M1 and M3, following different tablet formulations compared to a reference tablet
4 secondary outcomes
Incidence of Treatment-Emergent Adverse Events
Time frame: 17 weeks
Pharmacokinetic parameters, Cmax
Time frame: 17 weeks
Pharmacokinetic parameters, Tmax
Time frame: 17 weeks
Pharmacokinetic parameters, AUC
Time frame: 17 weeks
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 2 Nov 2018.
- Individual participant dataSharing planned: Undecided
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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.
Claudia Ordonez study chair
Flatley Discovery Lab
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 FDL169 in people with Cystic Fibrosis, run by Flatley Discovery Lab LLC at 1 site in United Kingdom.
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 4 inclusion and 11 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 2 Nov 2018. 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 United Kingdom. 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?
Relative bioavailability of FDL169 and its metabolites with different formulations (time frame: 17 weeks). 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 2 Nov 2018.