Cystic FibrosisPhase 1NCT03424252
An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations 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
Two parts, two periods, crossover study with part 2 is optional. In both parts, subjects will be randomized to sequentially receive both sublingual and oral formulations of FDL169. 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
- 18 Dec 2017to 15 Jan 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 males or non-pregnant, non-lactating healthy females
- Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must agree to follow the study's contraception requirement Subject has normal healthy oral mucosa with no clinically significant findings
Who cannot join
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- Subjects who have previously received FDL169
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months
- Females of childbearing potential who are pregnant or lactating (all female subjects must have a negative urine pregnancy test at screening and each admission). A woman is considered of childbearing potential unless she is permanently sterile (hysterectomy, bilateral salpingectomy and bilateral oophorectomy) or is postmenopausal (had no menses for 12 months without an alternative medical cause and a serum follicle-stimulating hormone [FSH] concentration >40 mIU/mL)
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- Alkaline phosphatase, aspartate aminotransferase and/or alanine aminotransferase level >1.5 x upper limit of normal at screening
- Abnormal renal function at screening, defined as estimated glomerular filtration rate <60 mL/min using the Modification of Diet in Renal Disease (MDRD) equation
- Clinically significant abnormal biochemistry, haematology, coagulation or urinalysis as judged by the investigator (laboratory parameters are listed in)
- Positive drugs of abuse test result
- 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 gastrointestinal disease, neurological or psychiatric disorder, as judged by the investigator
- Subjects with a history of abdominal surgery eg cholecystectomy (appendectomy is allowed unless procedure was within 12 months)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Crossover, Randomised Study to Evaluate the Pharmacokinetic Profile of FDL169 Sublingual Formulations in the Fed State in Healthy Subjects
Two parts, two periods, crossover study with part 2 is optional. In both parts, subjects will be randomized to sequentially receive both sublingual and oral formulations of FDL169.
Read the detailed description
This is a single center, open label study on healthy volunteers. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data. Part 1 and optional Part 2 have randomized, 2 period crossover designs. Subjects will randomized to 1 of 2 treatment sequences in order to receive 2 single doses of FDL169 on separate occasions, one as a sublingual administration and one as an oral administration. There will be a minimum washout period of 10 days between FDL169 administrations. The duration of each part is approximately 7 weeks from screening to follow up.
- 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
Cystic Fibrosis Transmembrane Regulator (CFTR) corrector
| Study group | Role | What they receive |
|---|---|---|
| FDL169 Dose Level 1,sublingual to oral | Experimental | Dose level 1 sublingual first and oral second. Receives: Drug: FDL169 |
| FDL169 Dose Level 1 dosing,oral to sublingual | Experimental | Dose level 1 oral first and sublingual second. Receives: Drug: FDL169 |
| FDL169 Dose Level 2 sublingual to oral,Optional | Experimental | Dose level 2 sublingual first and oral second. Receives: Drug: FDL169 |
| FDL169 Dose Level 2 oral to sublingual,Optional | Experimental | Dose level 2 oral first and sublingual second. Receives: Drug: FDL169 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetic parameters, Cmax
The pharmacokinetic parameters of FDL169; maximal plasma concentration (Cmax)
Measured: 7 weeks
Pharmacokinetic parameters, Tmax
The pharmacokinetic parameters of FDL169; maximal concentration (Tmax)
Measured: 7 weeks
Pharmacokinetic parameters, AUC
The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC)
Measured: 7 weeks
Pharmacokinetic parameters, CL/F
The pharmacokinetic parameters of FDL169; clearance (CL/F)
Measured: 7 weeks
Pharmacokinetic parameters, V/F
The pharmacokinetic parameters of FDL169; apparent volume of distribution (V/F)
Measured: 7 weeks
Ratio of pharmacokinetic parameters, AUC, between sublingual and oral formulation
The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC) of FDL169 and its M1 metabolite following sublingual dosing compared to oral dosing
Measured: 7 weeks
Secondary outcomes (1)
Incidence of Treatment-Emergent Adverse Events
Safety and tolerability of FDL169 as determined by the incidence of adverse events (Aes) and serious adverse events (SAE)s.
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2018
- Study start18 Dec 2017
- Primary completion15 Jan 2018
- Study completion15 Jan 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03424252
- Sponsor's protocol ID
- FDL169-2017-05
- Status last verified
- Feb 2018
- First submitted
- 31 Jan 2018
- Last updated
- 2 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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, Crossover, Randomised Study to Evaluate the Pharmacokinetic Profile of FDL169 Sublingual Formulations in the Fed State in Healthy Subjects
- ClinicalTrials.gov ID
- NCT03424252
- Acronym / sponsor ID
- FDL169-2017-05
- 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
- 18 Dec 2017 (actual)
- Primary completion
- 15 Jan 2018 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 6 Feb 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.
Two parts, two periods, crossover study with part 2 is optional. In both parts, subjects will be randomized to sequentially receive both sublingual and oral formulations of FDL169.
Detailed description
This is a single center, open label study on healthy volunteers. The study will consist of up to 2 parts; the decision to proceed to the optional second part will be made following review of Part 1 data. Part 1 and optional Part 2 have randomized, 2 period crossover designs. Subjects will randomized to 1 of 2 treatment sequences in order to receive 2 single doses of FDL169 on separate occasions, one as a sublingual administration and one as an oral administration. There will be a minimum washout period of 10 days between FDL169 administrations. The duration of each part is approximately 7 weeks from screening to follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| FDL169 Dose Level 1,sublingual to oral | Experimental | Drug: FDL169Dose level 1 sublingual first and oral second. |
| FDL169 Dose Level 1 dosing,oral to sublingual | Experimental | Drug: FDL169Dose level 1 oral first and sublingual second. |
| FDL169 Dose Level 2 sublingual to oral,Optional | Experimental | Drug: FDL169Dose level 2 sublingual first and oral second. |
| FDL169 Dose Level 2 oral to sublingual,Optional | Experimental | Drug: FDL169Dose level 2 oral first and sublingual second. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy males or non-pregnant, non-lactating healthy females
- Body mass index of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
- Must agree to follow the study's contraception requirement Subject has normal healthy oral mucosa with no clinically significant findings
Key exclusion criteria (13 listed)
- Subjects who have received any IMP in a clinical research study within the previous 3 months
- Subjects who have previously received FDL169
- History of any drug or alcohol abuse in the past 2 years
- Regular alcohol consumption in males >21 units per week and females >14 units per week (1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
- Current smokers and those who have smoked within the last 12 months
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 |
|---|---|---|
| FDL169Cystic Fibrosis Transmembrane Regulator (CFTR) corrector | Drug | FDL169 Dose Level 1 dosing,oral to sublingual, FDL169 Dose Level 1,sublingual to oral, FDL169 Dose Level 2 oral to sublingual,Optional, FDL169 Dose Level 2 sublingual to oral,Optional |
Primary outcome
Pharmacokinetic parameters, Cmax
Time frame: 7 weeks
The pharmacokinetic parameters of FDL169; maximal plasma concentration (Cmax)
Pharmacokinetic parameters, Tmax
Time frame: 7 weeks
The pharmacokinetic parameters of FDL169; maximal concentration (Tmax)
Pharmacokinetic parameters, AUC
Time frame: 7 weeks
The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC)
Pharmacokinetic parameters, CL/F
Time frame: 7 weeks
The pharmacokinetic parameters of FDL169; clearance (CL/F)
Pharmacokinetic parameters, V/F
Time frame: 7 weeks
The pharmacokinetic parameters of FDL169; apparent volume of distribution (V/F)
Ratio of pharmacokinetic parameters, AUC, between sublingual and oral formulation
Time frame: 7 weeks
The pharmacokinetic parameters of FDL169; area under the plasma concentration curve (AUC) of FDL169 and its M1 metabolite following sublingual dosing compared to oral dosing
1 secondary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 7 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 3 inclusion and 13 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?
Pharmacokinetic parameters, Cmax (time frame: 7 weeks). The study lists 6 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 2 Nov 2018.