Cystic FibrosisPhase 1NCT02680418
Pharmacokinetics of FDL169 in Healthy Female 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
To determine the pharmacokinetics of single and multiple doses of FDL169 in healthy female subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- FDL169
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Dec 2015to Feb 2016
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy female subjects aged 18 to 55 years inclusive and of any ethnic origin with a body mass index (BMI) of > 19 and < 30 kg/m2. Body Mass Index = Body weight (kg) / [Height (m)]
- Subjects must be willing to use an effective method of contraception from first dose of investigational medicinal product (IMP) and for 3 months after the last dose of IMP (unless they are of non-child bearing potential).
Who cannot join
- Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months.
- Subjects who have any renal or clinically significant cardiac, renal or hepatic disease at Screening.
- Subjects who have history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (with the exception of Gilbert's syndrome or asymptomatic gallstones), endocrine or immunologic disease at Screening.
- Have an abnormal twelve-lead ECG or an ECG with abnormality considered to be clinically significant in the opinion of the Investigator or an ECG with a single QTcB > 450 mSec.
- Subjects with a positive urinary drugs of abuse screen or positive alcohol screen at Screening or Day -1.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of > 21 units.
Show all 11Show fewer
- Subject with history of HIV or positive human immunodeficiency virus, hepatitis B or hepatitis C results.
- Donation of 500 mL or more of blood within the previous 3 months.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and FDL Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Smoking or use of tobacco products or substitutes equivalent to > 15 cigarettes/day.
- Any subject who is pregnant or nursing.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Simbec Research Ltd
Merthyr Tydfil, Wales, CF48 4DR
About this study
Official title: A Phase I Dose Escalation Study to Assess the Pharmacokinetics (PK) of FDL169 in Healthy Female Volunteers
To determine the pharmacokinetics of single and multiple doses of FDL169 in healthy female subjects.
Read the detailed description
This is a two-part study.
Part 1:
Part 1 of the study is a single-dose, dose-escalation, study to assess the safety, tolerability and PK profiles following oral administrations of FDL169 to healthy female volunteers in the fed state. Up to five doses will be assessed.
Part 2:
Part 2 of the study is a multiple-dose study to assess the safety, tolerability and PK profiles following oral administrations of FDL169 to healthy female volunteers in the fed state.
- Conditions
- Cystic Fibrosis
- Being tested
- FDL169
- 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
| Study group | Role | What they receive |
|---|---|---|
| Single dose (Dose level 1) | Experimental | FDL169 (Dose level 1) administered as a single dose Receives: Drug: FDL169 |
| Single dose (Dose level 2) | Experimental | FDL169 (Dose level 2) administered as a single dose Receives: Drug: FDL169 |
| Single dose (Dose level 3) | Experimental | FDL169 (Dose level 3) administered as a single dose Receives: Drug: FDL169 |
| Single dose (Dose level 4) | Experimental | FDL169 (Dose level 4) administered as a single dose Receives: Drug: FDL169 |
| Single dose (Dose level 5) | Experimental | FDL169 (Dose level 5) administered as a single dose Receives: Drug: FDL169 |
| Multiple dose | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined Receives: Drug: FDL169 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1: Maximum plasma concentration of FDL169 (and metabolites) over 48 h following single oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post-dose
Part 1: Time to maximum plasma concentration of FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: Terminal half-life of FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: Clearance of FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: AUC% extrapolated for FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 2: Maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Measured: Multiple points from pre-dose to 48 h post-final dose
Part 2: Time to maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Measured: Multiple points from pre-dose to 48 h post-final dose
Part 2: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Measured: Multiple points from pre-dose to 48 h post-final dose
Part 2: Terminal half-life of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Measured: Multiple points from pre-dose to 48 h post-final dose
Part 2: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Measured: Multiple points from pre-dose to 48 h post-final dose
Part 2: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Measured: Multiple points from pre-dose to 48 h post-final dose
Part 2: AUC from the time of dosing to time t at steady state for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Measured: Multiple points from pre-dose to 48 h post-final dose
Part 2: Clearance of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Measured: Multiple points from pre-dose to 48 h post-final dose
Part 2: AUC% extrapolated for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Measured: Multiple points from pre-dose to 48 h post-final dose
Secondary outcomes (8)
Number of patients with clinically significant changes in systolic blood pressure following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Measured: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with clinically significant changes in diastolic blood pressure following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Measured: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with clinically significant changes in pulse rate following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Measured: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with clinically significant changes in oxygen saturation following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Measured: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with clinically significant changes in oral temperature following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Measured: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with clinically significant 12-lead ECG abnormalities following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Measured: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with abnormal laboratory values following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Measured: Multiple points from pre-dose to 48 h post (last) dose
Number of patients experiencing treatment-related adverse events following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Measured: Multiple points from pre-dose to 48 h post (last) dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2016 (estimated)
- Study startDec 2015
- Primary completionFeb 2016
- Study completionFeb 2016
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
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flatley Discovery Lab LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Khalid Abou-Farha, MBChB MD PhD, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680418
- Sponsor's protocol ID
- FDL169-2015-02
- Status last verified
- Mar 2016
- First submitted
- 2 Feb 2016
- Last updated
- 31 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study to Assess the Pharmacokinetics (PK) of FDL169 in Healthy Female Volunteers
- ClinicalTrials.gov ID
- NCT02680418
- Acronym / sponsor ID
- FDL169-2015-02
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Flatley Discovery Lab LLCUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Feb 2016 (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.
To determine the pharmacokinetics of single and multiple doses of FDL169 in healthy female subjects.
Detailed description
This is a two-part study.
Part 1:
Part 1 of the study is a single-dose, dose-escalation, study to assess the safety, tolerability and PK profiles following oral administrations of FDL169 to healthy female volunteers in the fed state. Up to five doses will be assessed.
Part 2:
Part 2 of the study is a multiple-dose study to assess the safety, tolerability and PK profiles following oral administrations of FDL169 to healthy female volunteers in the fed state.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Single dose (Dose level 1) | Experimental | Drug: FDL169FDL169 (Dose level 1) administered as a single dose |
| Single dose (Dose level 2) | Experimental | Drug: FDL169FDL169 (Dose level 2) administered as a single dose |
| Single dose (Dose level 3) | Experimental | Drug: FDL169FDL169 (Dose level 3) administered as a single dose |
| Single dose (Dose level 4) | Experimental | Drug: FDL169FDL169 (Dose level 4) administered as a single dose |
| Single dose (Dose level 5) | Experimental | Drug: FDL169FDL169 (Dose level 5) administered as a single dose |
| Multiple dose | Experimental | Drug: FDL169Repeat doses of FDL169 to be administered at a dose level to be determined |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy female subjects aged 18 to 55 years inclusive and of any ethnic origin with a body mass index (BMI) of > 19 and < 30 kg/m2. Body Mass Index = Body weight (kg) / [Height (m)]
- Subjects must be willing to use an effective method of contraception from first dose of investigational medicinal product (IMP) and for 3 months after the last dose of IMP (unless they are of non-child bearing potential).
Key exclusion criteria (11 listed)
- Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months.
- Subjects who have any renal or clinically significant cardiac, renal or hepatic disease at Screening.
- Subjects who have history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (with the exception of Gilbert's syndrome or asymptomatic gallstones), endocrine or immunologic disease at Screening.
- Have an abnormal twelve-lead ECG or an ECG with abnormality considered to be clinically significant in the opinion of the Investigator or an ECG with a single QTcB > 450 mSec.
- Subjects with a positive urinary drugs of abuse screen or positive alcohol screen at Screening or Day -1.
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 |
|---|---|---|
| FDL169 | Drug | Multiple dose, Single dose (Dose level 1), Single dose (Dose level 2), Single dose (Dose level 3), Single dose (Dose level 4), Single dose (Dose level 5) |
Primary outcome
Part 1: Maximum plasma concentration of FDL169 (and metabolites) over 48 h following single oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dose
Part 1: Time to maximum plasma concentration of FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: Terminal half-life of FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: Clearance of FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 1: AUC% extrapolated for FDL169 (and metabolites) during 48 h following single oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dosing on Day 7
Part 2: Maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Time frame: Multiple points from pre-dose to 48 h post-final dose
Part 2: Time to maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Time frame: Multiple points from pre-dose to 48 h post-final dose
Part 2: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Time frame: Multiple points from pre-dose to 48 h post-final dose
Part 2: Terminal half-life of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Time frame: Multiple points from pre-dose to 48 h post-final dose
Part 2: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Time frame: Multiple points from pre-dose to 48 h post-final dose
Part 2: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Time frame: Multiple points from pre-dose to 48 h post-final dose
Part 2: AUC from the time of dosing to time t at steady state for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Time frame: Multiple points from pre-dose to 48 h post-final dose
Part 2: Clearance of FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Time frame: Multiple points from pre-dose to 48 h post-final dose
Part 2: AUC% extrapolated for FDL169 (and metabolites) following multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post-final dose)
Time frame: Multiple points from pre-dose to 48 h post-final dose
8 secondary outcomes
Number of patients with clinically significant changes in systolic blood pressure following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Time frame: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with clinically significant changes in diastolic blood pressure following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Time frame: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with clinically significant changes in pulse rate following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Time frame: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with clinically significant changes in oxygen saturation following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Time frame: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with clinically significant changes in oral temperature following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Time frame: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with clinically significant 12-lead ECG abnormalities following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Time frame: Multiple points from pre-dose to 48 h post (last) dose
Number of patients with abnormal laboratory values following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Time frame: Multiple points from pre-dose to 48 h post (last) dose
Number of patients experiencing treatment-related adverse events following single and multiple oral doses of FDL169 (assessed throughout dosing and for 48 h post (final) dose)
Time frame: Multiple points from pre-dose to 48 h post (last) dose
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 31 Mar 2016.
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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.
Khalid Abou-Farha, MBChB MD PhD principal investigator
Simbec Research
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 2 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 31 Mar 2016. 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?
Part 1: Maximum plasma concentration of FDL169 (and metabolites) over 48 h following single oral doses of FDL169 (time frame: Multiple points from pre-dose to 48 h post-dose). The study lists 17 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 31 Mar 2016.