Cystic FibrosisPhase 1NCT03173573
A Study to Assess the Safety, Tolerability and PK Profile of FDL176 in Healthy and CF Participants
A Phase 1 study testing FDL176 in people with Cystic Fibrosis, run by Flatley Discovery Lab LLC at 3 sites in Australia.
Trial summary
This is a 5-part study of FDL176. Part 1 is a double blind, placebo-controlled, dose escalation study in healthy male participants. Part 2 is a single dose, open-label study in healthy male participants. Part 3 is a single dose, double blind, placebo-controlled study in healthy female participants. 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?
- FDL176
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 109 participants
- Where
- 3 sitesAustralia
- Study dates
- 27 Jun 2017to 31 May 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
- If sexually active, must be willing to use two highly effective methods of birth control from Day 1 until 3 months after the last dose of investigational medicinal product (IMP)
- Body mass index (BMI) between 19 and 30 kg/m2 inclusive.
- Healthy as determined by the PI or delegate, based upon a medical evaluation including medical history, physical examination, laboratory tests and ECG.
- Males and females aged 18 years and older.
- Diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative pilocarpine iontophoresis or two CF-causing mutations, documented in the participant's medical record.
- History of pancreatic insufficiency, documented in the participant's medical record.
- Stable CF disease as judged by the Investigator (or delegate).
- Forced expiratory volume in one second (FEV1) >40% of predicted normal for age, sex and height at screening.
Who cannot join
- Prior or ongoing medical condition, medical history, physical findings, ECG findings or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of PK of the participant or would place the participant at increased risk.
- Surgery within the past three months prior to the first study drug administration determined by the PI or delegate to be clinically relevant.
- Alkaline phosphatase (ALP), aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN) at screening. Repeat testing at screening is acceptable for out of range values following approval by the Sponsor's Medical Monitor.
- 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%).
- Abnormal renal function at screening, defined as creatinine clearance <60 mL/min using the Modification of Diet in Renal Disease (MDRD) equation
- History of prolonged QT and/or QTcF interval.
Show all 26Show fewer
- 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 Screening or Day -1
- History of human immunodeficiency virus (HIV) or positive HIV, hepatitis B or hepatitis C results at screening.
- Use of any prescription drugs within 14 days or 5 half-lives (whichever is longer) before the first dose of IMP, unless in the opinion of the Investigator (or delegate) and the Sponsor's Medical Monitor the medication will not interfere with the study procedures or compromise participant safety. Hormonal contraceptives are allowed.
- Use of any non-prescription drugs, including vitamins, herbal and dietary supplements within 14 days or 5 half-lives (whichever is longer) before the first dose of IMP, unless in the opinion of the Investigator (or delegate) and the Sponsor's Medical Monitor the medication will not interfere with the study procedures or compromise participant safety.
- Pregnant or nursing females. Female participants of childbearing potential must have a negative pregnancy test at the screening visit. Determination of participant eligibility will be at the discretion of the Investigator (or delegate) following consultation with the Sponsor's Medical Monitor.
- History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units. One unit is equivalent to 8 g of alcohol: a half-pint (~240 mL) of beer, one glass (125 mL) of wine, or one (25 mL) measure of spirits.
- 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.
- Participation in another clinical trial involving receipt of an IMP within the past 90 days or exposure to more than four new chemical entities with 12 months of the first dosing day.
- A pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks prior to the Baseline (Day 1) visit.
- Abnormal liver function ≥3 × ULN: AST, ALT, total bilirubin.
- 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%).
- Abnormal renal function at screening, defined as creatinine clearance <60 mL/min using the MDRD equation.
- Hemoglobin <10 g/dL.
- History of prolonged QT and/or QTcF interval.
- ECG with a single QTcF >450 msec in males, >460 msec in females, at Screening.
- Use of ivacaftor or lumacaftor within 14 days prior to Day 1.
- Any change (initiation, change in type of drug, dose modification, schedule modification, interruption, discontinuation, or re-initiation) in a chronic treatment/prophylaxis regimen for CF or CF related conditions within 4 weeks prior to Day 1.
- Pregnant or nursing females. Female participants of childbearing potential must have a negative pregnancy test at the screening visit. Determination of participant eligibility will be at the discretion of the Investigator (or delegate) following consultation with the Sponsor's Medical Monitor.
- Participation in another clinical trial involving receipt of an IP within the past 90 days or exposure to more than four new chemical entities with 12 months of the first dosing day.
Trial locations and contacts
3 sites in 1 country.
Australia3 sites
Wayne Hooper Clinic Clive Berghofer Cancer research Center
Herston, Queenland, 4006
Linear Clinical Research
Perth, Western Australia, 6009
Mater Hospital
South Brisbane, Queensland, 4101
About this study
Official title: A Five Part Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Single and Repeat Oral Doses of FDL176 in Healthy and Cystic Fibrosis (CF) Participants
This is a 5-part study of FDL176. Part 1 is a double blind, placebo-controlled, dose escalation study in healthy male participants. Part 2 is a single dose, open-label study in healthy male participants. Part 3 is a single dose, double blind, placebo-controlled study in healthy female participants. Part 4 is a randomised, double-blind, placebo-controlled, dose-escalation study in healthy male and female participants.Part 5 is a single dose, open-label study in male and female participants with CF.
Read the detailed description
This is a 5-part study. Part 1 is a double blind, placebo-controlled, dose escalation, first-in-human study to assess the safety, tolerability and PK profiles following single oral administration of FDL176 to healthy male participants. Part 2 is a single dose, open-label study in healthy male participants to determine the effect of food on the PK profile of FDL176. Part 3 is a single dose, double blind, placebo-controlled study in healthy female participants to assess the PK, safety and tolerability profiles of FDL176. Part 4 is a randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK profiles following multiple oral administrations of FDL176 to healthy male and female participants. Part 5 is a single dose, open-label study in male and female participants with CF to determine the PK profile of FDL176.
- Conditions
- Cystic Fibrosis
- Being tested
- FDL176, Placebo
- 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.
FDL176Drug
CFTR modulator
PlaceboDrug
Placebo for FDL176
| Study group | Role | What they receive |
|---|---|---|
| Part 1 SAD FDL176 level 1 to 6 | Experimental | Part 1: Single dose of FDL176 test formulation Level 1 to 6 on healthy males. Receives: Drug: FDL176 |
| Part 1 SAD Placebo | Placebo comparator | Part 1: Single dose of Placebo for FDL176. Receives: Drug: Placebo |
| Part 2 SAD FDL176 at fasted state | Experimental | Part 2: single dose of FDL176 test formulation, fasted state. Receives: Drug: FDL176 |
| Part 2 SAD FDL176 at fed state | Experimental | Part 2: single dose of FDL176 test formulation, fed state Receives: Drug: FDL176 |
| Part 3 SAD FDL176 test formulation | Experimental | Part 3: Single dose of FDL176 test formulation on healthy females. Receives: Drug: FDL176 |
| Part 3 SAD placebo | Placebo comparator | Part 3: Single dose of Placebo for FDL176. Receives: Drug: Placebo |
| Part 4 MAD FDL176 Level 1 to 3 | Experimental | Part 4: Dose escalation of FDL176 test formulation Level 1 to 3. Receives: Drug: FDL176 |
| Part 4 MAD Placebo | Placebo comparator | Part 4: Dose escalation of Placebo for FDL176 Level 1 to 3. Receives: Drug: Placebo |
| Part 5 SAD FDL176 test formulation | Experimental | Part 5: Single dose of FDL176 test formulation. Receives: Drug: FDL176 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and Part 4: Incidence of Treatment-Emergent Adverse Events.
Part 1 and Part 4: Safety and tolerability of FDL176 in healthy male participants as determined by the incidence of adverse events (AE)s and serious adverse events(SAE)s.
Measured: Part 1: 4 weeks; Part 4: 6 weeks
Part 2, 3 and 5: Pharmacokinetic parameters, Cmax
The pharmacokinetic parameters of FDL176: maximal plasma concentration
Measured: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 2, 3 and 5: Pharmacokinetic parameters, Tmax
The pharmacokinetic parameters of FDL176: maximal concentration
Measured: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 2, 3 and 5: Pharmacokinetic parameters, AUC
The pharmacokinetic parameters of FDL176: area under the plasma concentration curve
Measured: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 2, 3 and 5: Pharmacokinetic parameters, CL/F
The pharmacokinetic parameters of FDL176: clearance
Measured: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 2, 3 and 5: Pharmacokinetic parameters, V/F
The pharmacokinetic parameters of FDL176: apparent volume of distribution
Measured: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Secondary outcomes (6)
Part 2, 3, and 5: Incidence of Treatment-Emergent Adverse Events.
Safety and tolerability of FDL176 in healthy male participants as determined by the incidence of adverse events (AE)s and serious adverse events(SAE)s.
Measured: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 1 and 4: Pharmacokinetic parameters, Cmax
The pharmacokinetic parameters of FDL176: maximal plasma concentration
Measured: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters,Tmax
The pharmacokinetic parameters of FDL176: maximal concentration
Measured: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters,AUC
The pharmacokinetic parameters of FDL176: area under the plasma concentration curve
Measured: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters, CL/F
The pharmacokinetic parameters of FDL176: clearance
Measured: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters, V/F
The pharmacokinetic parameters of FDL176: apparent volume of distribution
Measured: Part 1: 4 weeks; Part 4: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start27 Jun 2017
- Primary completion31 May 2018
- Study completion31 May 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
- Parallel groups
- Model description
- 5-part study. Part 1,3,4: parallel assignment; Part 2: cross over assignment; Part 5: single assignment
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flatley Discovery Lab LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claudia Ordonez, MD, Study chair, Flatley Discovery Lab
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03173573
- Sponsor's protocol ID
- FDL176-2016-01
- Status last verified
- Sep 2018
- First submitted
- 30 May 2017
- Last updated
- 6 Sep 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 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Five Part Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Single and Repeat Oral Doses of FDL176 in Healthy and Cystic Fibrosis (CF) Participants
- ClinicalTrials.gov ID
- NCT03173573
- Acronym / sponsor ID
- FDL176-2016-01
- Conditions
- Cystic Fibrosis
- Keywords
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Flatley Discovery Lab LLCUniversity, hospital or other
- Study start
- 27 Jun 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 2 Jun 2017 (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 5-part study of FDL176. Part 1 is a double blind, placebo-controlled, dose escalation study in healthy male participants. Part 2 is a single dose, open-label study in healthy male participants. Part 3 is a single dose, double blind, placebo-controlled study in healthy female participants. Part 4 is a randomised, double-blind, placebo-controlled, dose-escalation study in healthy male and female participants.Part 5 is a single dose, open-label study in male and female participants with CF.
Detailed description
This is a 5-part study. Part 1 is a double blind, placebo-controlled, dose escalation, first-in-human study to assess the safety, tolerability and PK profiles following single oral administration of FDL176 to healthy male participants. Part 2 is a single dose, open-label study in healthy male participants to determine the effect of food on the PK profile of FDL176. Part 3 is a single dose, double blind, placebo-controlled study in healthy female participants to assess the PK, safety and tolerability profiles of FDL176. Part 4 is a randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK profiles following multiple oral administrations of FDL176 to healthy male and female participants. Part 5 is a single dose, open-label study in male and female participants with CF to determine the PK profile of FDL176.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 9
- Model description
- 5-part study. Part 1,3,4: parallel assignment; Part 2: cross over assignment; Part 5: single assignment
| Arm | Type | Receives |
|---|---|---|
| Part 1 SAD FDL176 level 1 to 6 | Experimental | Drug: FDL176Part 1: Single dose of FDL176 test formulation Level 1 to 6 on healthy males. |
| Part 1 SAD Placebo | Placebo comparator | Drug: PlaceboPart 1: Single dose of Placebo for FDL176. |
| Part 2 SAD FDL176 at fasted state | Experimental | Drug: FDL176Part 2: single dose of FDL176 test formulation, fasted state. |
| Part 2 SAD FDL176 at fed state | Experimental | Drug: FDL176Part 2: single dose of FDL176 test formulation, fed state |
| Part 3 SAD FDL176 test formulation | Experimental | Drug: FDL176Part 3: Single dose of FDL176 test formulation on healthy females. |
| Part 3 SAD placebo | Placebo comparator | Drug: PlaceboPart 3: Single dose of Placebo for FDL176. |
| Part 4 MAD FDL176 Level 1 to 3 | Experimental | Drug: FDL176Part 4: Dose escalation of FDL176 test formulation Level 1 to 3. |
| Part 4 MAD Placebo | Placebo comparator | Drug: PlaceboPart 4: Dose escalation of Placebo for FDL176 Level 1 to 3. |
| Part 5 SAD FDL176 test formulation | Experimental | Drug: FDL176Part 5: Single dose of FDL176 test formulation. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- If sexually active, must be willing to use two highly effective methods of birth control from Day 1 until 3 months after the last dose of investigational medicinal product (IMP)
- Body mass index (BMI) between 19 and 30 kg/m2 inclusive.
- Healthy as determined by the PI or delegate, based upon a medical evaluation including medical history, physical examination, laboratory tests and ECG.
- Males and females aged 18 years and older.
- Diagnosis of CF defined as a sweat chloride value ≥60 mmol/L by quantitative pilocarpine iontophoresis or two CF-causing mutations, documented in the participant's medical record.
Key exclusion criteria (26 listed)
- Prior or ongoing medical condition, medical history, physical findings, ECG findings or laboratory abnormality that, in the Investigator's (or delegate's) opinion, could adversely affect the safety of PK of the participant or would place the participant at increased risk.
- Surgery within the past three months prior to the first study drug administration determined by the PI or delegate to be clinically relevant.
- Alkaline phosphatase (ALP), aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >1.5 x upper limit of normal (ULN) at screening. Repeat testing at screening is acceptable for out of range values following approval by the Sponsor's Medical Monitor.
- 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%).
- Abnormal renal function at screening, defined as creatinine clearance <60 mL/min using the Modification of Diet in Renal Disease (MDRD) equation
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 |
|---|---|---|
| FDL176CFTR modulator | Drug | Part 1 SAD FDL176 level 1 to 6, Part 2 SAD FDL176 at fasted state, Part 2 SAD FDL176 at fed state, Part 3 SAD FDL176 test formulation, Part 4 MAD FDL176 Level 1 to 3, Part 5 SAD FDL176 test formulation |
| PlaceboPlacebo for FDL176 | Drug | Part 1 SAD Placebo, Part 3 SAD placebo, Part 4 MAD Placebo |
Primary outcome
Part 1 and Part 4: Incidence of Treatment-Emergent Adverse Events.
Time frame: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and Part 4: Safety and tolerability of FDL176 in healthy male participants as determined by the incidence of adverse events (AE)s and serious adverse events(SAE)s.
Part 2, 3 and 5: Pharmacokinetic parameters, Cmax
Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
The pharmacokinetic parameters of FDL176: maximal plasma concentration
Part 2, 3 and 5: Pharmacokinetic parameters, Tmax
Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
The pharmacokinetic parameters of FDL176: maximal concentration
Part 2, 3 and 5: Pharmacokinetic parameters, AUC
Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
The pharmacokinetic parameters of FDL176: area under the plasma concentration curve
Part 2, 3 and 5: Pharmacokinetic parameters, CL/F
Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
The pharmacokinetic parameters of FDL176: clearance
Part 2, 3 and 5: Pharmacokinetic parameters, V/F
Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
The pharmacokinetic parameters of FDL176: apparent volume of distribution
6 secondary outcomes
Part 2, 3, and 5: Incidence of Treatment-Emergent Adverse Events.
Time frame: Part 2: 5 weeks, Part 3: 4 weeks and Part 5: 4 weeks
Part 1 and 4: Pharmacokinetic parameters, Cmax
Time frame: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters,Tmax
Time frame: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters,AUC
Time frame: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters, CL/F
Time frame: Part 1: 4 weeks; Part 4: 6 weeks
Part 1 and 4: Pharmacokinetic parameters, V/F
Time frame: Part 1: 4 weeks; Part 4: 6 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 6 Sep 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, MD study chair
Flatley Discovery Lab
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FDL176 in people with Cystic Fibrosis, run by Flatley Discovery Lab LLC at 3 sites 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 8 inclusion and 26 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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. Some participants in this study may receive a placebo. 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 and Part 4: Incidence of Treatment-Emergent Adverse Events. (time frame: Part 1: 4 weeks; Part 4: 6 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 6 Sep 2018.