Cystic FibrosisPhase 1/2NCT02767297
Bioavailability and Pharmacokinetics Study of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis
A Phase 1/2 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 relative bioavailability of the capsule (reference) and tablet (test) formulations of FDL169 in healthy adult males and females, and to evaluate the pharmacokinetic (PK) profile FDL169 tablets (test formulation) in both healthy adult males and females, and subjects with cystic fibrosis (CF). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy 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
- 46 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Oct 2016
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parts 1 and 2:
- Healthy, males and females between 18 and 55 years of age, inclusive, with a BMI of >19 and <30 kg/m2.
- If sexually active, must meet the contraception requirements.
- Part 3:
- Male and female subjects aged 18 years and older.
- If sexually active, must meet the contraception requirements.
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- Diagnosis of CF.
- History of pancreatic insufficiency.
- Forced expiratory volume in 1 second (FEV1) ≥40% of predicted normal for age, sex and height at screening.
Who cannot join
- Parts 1 and 2:
- Prior or ongoing medical condition, medical history, physical findings, ECG findings or laboratory abnormality that could adversely affect the safety of the subject.
- Alkaline phosphatase, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) level >1.5 x upper limit of normal (ULN) at screening.
- Use of prescription or non-prescription drugs within 21 days or five half-lives (whichever is longer) before the first dose of study medication, unless the medication will not interfere with the study procedures or compromise subject safety.
- Pregnant or nursing females.
- Serum creatinine or total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%).
Show all 31Show fewer
- History of prolonged QT and/or QTcF interval.
- ECG with a single QTcF >450 msec in males, >460 msec in females, at Screening.
- Positive urinary drugs of abuse screen at Screening or Day -1, or positive alcohol screen at Day -1.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units.
- History of human immunodeficiency virus (HIV) or positive HIV, hepatitis B or hepatitis C results at screening.
- Donation of 500 mL or more blood within 3 months before Day -1.
- Participation in a clinical trial involving receipt of an investigational product within the past 90 days or exposure to more than four new chemical entities with 12 months of the first dosing day.
- Current smoking or use of tobacco products or substitutes. Former smokers will be eligible, provided they have not smoked for at least 6 months before Day -1.
- Use of any prescription and non-prescription medications that are inhibitors or inducers of cytochrome P450 (CYP) 3A4 within 7 days before Day -1.
- Part 3:
- History of any illness, or ongoing acute illness that could impact the safety of the subject or confound study results.
- Abnormal liver function ≥3 x ULN: AST, ALT, total bilirubin.
- A pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks prior to the Baseline (Day 1) Visit
- Use of herbal and dietary supplements within 21 days or five half-lives (whichever is longer) before the first dose of study medication, unless the medication will not interfere with the study procedures or compromise subject safety.
- Pregnant or nursing females.
- Serum creatinine or total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%).
- History of prolonged QT and/or QTcF interval.
- ECG with a single QTcF >450 msec in males, >460 msec in females, at Screening.
- Positive urinary drugs of abuse screen at Screening or Day -1, or positive alcohol screen at Day -1.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units.
- History of HIV, or positive HIV, hepatitis B or hepatitis C results at screening.
- Donation of 500 mL or more blood within 3 months before Day -1.
- Participation in a clinical trial involving receipt of an investigational product within the past 90 days or exposure to more than four new chemical entities with 12 months of the first dosing day.
- Current smoking or use of tobacco products or substitutes. Former smokers will be eligible, provided they have not smoked for at least 6 months before Day -1.
- Use of any prescription and non-prescription medications that are inhibitors or inducers of CYP3A4, within 7 days before Day -1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Three-Part Phase 1b Bioavailability and Pharmacokinetics Study of Two Formulations of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis
To determine the relative bioavailability of the capsule (reference) and tablet (test) formulations of FDL169 in healthy adult males and females, and to evaluate the pharmacokinetic (PK) profile FDL169 tablets (test formulation) in both healthy adult males and females, and subjects with cystic fibrosis (CF).
Read the detailed description
This is a three-part study.
Part 1:
Part 1 of the study is a single dose, open-label, randomized crossover study in healthy male and female subjects to compare the relative bioavailability of two formulations of FDL169.
Part 2:
Part 2 of the study is a multiple, escalating dose study of three different doses of the test formulation of FDL169 in healthy male and female subjects to evaluate the PK profile of the test formulation of FDL169.
Part 3:
Part 3 of the study is a single dose, open-label study in male and female subjects with CF to determine the PK profile of the test formulation of FDL169.
- 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 |
|---|---|---|
| Part 1: Single dose (cross over) | Experimental | FDL169 reference formulation and test formulation administered as a single dose in healthy subjects Receives: Drug: FDL169 |
| Part 2: Multiple dose (dose level 1) | Experimental | FDL169 test formulation (Dose level 1) administered as repeat doses in healthy subjects Receives: Drug: FDL169 |
| Part 2: Multiple dose (dose level 2) | Experimental | FDL169 test formulation (Dose level 2) administered as repeat doses in healthy subjects Receives: Drug: FDL169 |
| Part 2: Multiple dose (dose level 3) | Experimental | FDL169 test formulation (Dose level 3) administered as repeat doses in healthy subjects Receives: Drug: FDL169 |
| Part 3: Single dose | Experimental | FDL169 test formulation administered as a single dose in CF subjects 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) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 72 h post-dose
Part 1: Time to maximum plasma concentration of FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 72 h post-dose
Part 1: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 72 h post-dose
Part 1: Terminal half-life of FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 72 h post-dose
Part 1: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 72 h post-dose
Part 1: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 72 h post-dose
Part 1: Clearance of FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 72 h post-dose
Part 1: AUC% extrapolated for FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 72 h post-dose
Part 2: Maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post last dose
Part 2: Time to maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post last dose
Part 2: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following multiple oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post last dose
Part 2: Terminal half-life of FDL169 (and metabolites) following multiple oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post last 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 FDL169
Measured: Multiple points from pre-dose to 48 h post last 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
Measured: Multiple points from pre-dose to 48 h post last dose
Part 2: Clearance of FDL169 (and metabolites) following multiple oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post last dose
Part 2: AUC% extrapolated for FDL169 (and metabolites) following multiple oral doses of FDL169
Measured: Multiple points from pre-dose to 48 h post last dose
Part 3: Maximum plasma concentration of FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 48 h post-dose
Part 3: Time to maximum plasma concentration of FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 48 h post-dose
Part 3: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 48 h post-dose
Part 3: Terminal half-life of FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 48 h post-dose
Part 3: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 48 h post-dose
Part 3: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 48 h post-dose
Part 3: Clearance of FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 48 h post-dose
Part 3: AUC% extrapolated for FDL169 (and metabolites) following single oral dose of FDL169
Measured: Multiple points from pre-dose to 48 h post-dose
Secondary outcomes (7)
Number of subjects with clinically significant changes in systolic and diastolic blood pressure following single and multiple oral doses of FDL169
Measured: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects with clinically significant changes in heart rate following single and multiple oral doses of FDL169
Measured: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects with clinically significant changes in oral temperature following single and multiple oral doses of FDL169
Measured: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects with clinically significant changes in oxygen saturation following single and multiple oral doses of FDL169
Measured: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects with clinically significant 12-lead ECG abnormalities following single and multiple oral doses of FDL169
Measured: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects with abnormal laboratory values following single and multiple oral doses of FDL169
Measured: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects experiencing treatment-related adverse events following single and multiple oral doses of FDL169
Measured: Multiple points from screening to follow-up (7 days after last dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2016 (estimated)
- Study startApr 2016
- Primary completionOct 2016
- Study completionOct 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 1/2
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flatley Discovery Lab LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart Elborn, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02767297
- Sponsor's protocol ID
- FDL169-2015-03
- Status last verified
- Oct 2016
- First submitted
- 5 May 2016
- Last updated
- 24 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three-Part Phase 1b Bioavailability and Pharmacokinetics Study of Two Formulations of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT02767297
- Acronym / sponsor ID
- FDL169-2015-03
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Flatley Discovery Lab LLCUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 10 May 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 relative bioavailability of the capsule (reference) and tablet (test) formulations of FDL169 in healthy adult males and females, and to evaluate the pharmacokinetic (PK) profile FDL169 tablets (test formulation) in both healthy adult males and females, and subjects with cystic fibrosis (CF).
Detailed description
This is a three-part study.
Part 1:
Part 1 of the study is a single dose, open-label, randomized crossover study in healthy male and female subjects to compare the relative bioavailability of two formulations of FDL169.
Part 2:
Part 2 of the study is a multiple, escalating dose study of three different doses of the test formulation of FDL169 in healthy male and female subjects to evaluate the PK profile of the test formulation of FDL169.
Part 3:
Part 3 of the study is a single dose, open-label study in male and female subjects with CF to determine the PK profile of the test formulation of FDL169.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Part 1: Single dose (cross over) | Experimental | Drug: FDL169FDL169 reference formulation and test formulation administered as a single dose in healthy subjects |
| Part 2: Multiple dose (dose level 1) | Experimental | Drug: FDL169FDL169 test formulation (Dose level 1) administered as repeat doses in healthy subjects |
| Part 2: Multiple dose (dose level 2) | Experimental | Drug: FDL169FDL169 test formulation (Dose level 2) administered as repeat doses in healthy subjects |
| Part 2: Multiple dose (dose level 3) | Experimental | Drug: FDL169FDL169 test formulation (Dose level 3) administered as repeat doses in healthy subjects |
| Part 3: Single dose | Experimental | Drug: FDL169FDL169 test formulation administered as a single dose in CF subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy, males and females between 18 and 55 years of age, inclusive, with a BMI of >19 and <30 kg/m2.
- If sexually active, must meet the contraception requirements.
- Male and female subjects aged 18 years and older.
- If sexually active, must meet the contraception requirements.
- Diagnosis of CF.
Key exclusion criteria (31 listed)
- Prior or ongoing medical condition, medical history, physical findings, ECG findings or laboratory abnormality that could adversely affect the safety of the subject.
- Alkaline phosphatase, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) level >1.5 x upper limit of normal (ULN) at screening.
- Use of prescription or non-prescription drugs within 21 days or five half-lives (whichever is longer) before the first dose of study medication, unless the medication will not interfere with the study procedures or compromise subject safety.
- Pregnant or nursing females.
- Serum creatinine or total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin is <35%).
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 | Part 1: Single dose (cross over), Part 2: Multiple dose (dose level 1), Part 2: Multiple dose (dose level 2), Part 2: Multiple dose (dose level 3), Part 3: Single dose |
Primary outcome
Part 1: Maximum plasma concentration of FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 72 h post-dose
Part 1: Time to maximum plasma concentration of FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 72 h post-dose
Part 1: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 72 h post-dose
Part 1: Terminal half-life of FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 72 h post-dose
Part 1: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 72 h post-dose
Part 1: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 72 h post-dose
Part 1: Clearance of FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 72 h post-dose
Part 1: AUC% extrapolated for FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 72 h post-dose
Part 2: Maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post last dose
Part 2: Time to maximum plasma concentration of FDL169 (and metabolites) following multiple oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post last dose
Part 2: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following multiple oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post last dose
Part 2: Terminal half-life of FDL169 (and metabolites) following multiple oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post last 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 FDL169
Time frame: Multiple points from pre-dose to 48 h post last 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
Time frame: Multiple points from pre-dose to 48 h post last dose
Part 2: Clearance of FDL169 (and metabolites) following multiple oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post last dose
Part 2: AUC% extrapolated for FDL169 (and metabolites) following multiple oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post last dose
Part 3: Maximum plasma concentration of FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dose
Part 3: Time to maximum plasma concentration of FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dose
Part 3: Individual estimate of the terminal elimination rate constant of FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dose
Part 3: Terminal half-life of FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dose
Part 3: AUC from the time of dosing to the time of the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dose
Part 3: AUC extrapolated to infinity from dosing time, based on the last observed concentration for FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dose
Part 3: Clearance of FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dose
Part 3: AUC% extrapolated for FDL169 (and metabolites) following single oral dose of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dose
7 secondary outcomes
Number of subjects with clinically significant changes in systolic and diastolic blood pressure following single and multiple oral doses of FDL169
Time frame: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects with clinically significant changes in heart rate following single and multiple oral doses of FDL169
Time frame: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects with clinically significant changes in oral temperature following single and multiple oral doses of FDL169
Time frame: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects with clinically significant changes in oxygen saturation following single and multiple oral doses of FDL169
Time frame: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects with clinically significant 12-lead ECG abnormalities following single and multiple oral doses of FDL169
Time frame: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects with abnormal laboratory values following single and multiple oral doses of FDL169
Time frame: Multiple points from screening to follow-up (7 days after last dose)
Number of subjects experiencing treatment-related adverse events following single and multiple oral doses of FDL169
Time frame: Multiple points from screening to follow-up (7 days after 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 24 Oct 2016.
- 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.
Stuart Elborn, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 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 9 inclusion and 31 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 24 Oct 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 combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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) following single oral dose of FDL169 (time frame: Multiple points from pre-dose to 72 h post-dose). The study lists 24 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 24 Oct 2016.