Cystic FibrosisPhase 1NCT02359357
FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
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 safety and tolerability of single and multiple escalating doses of FDL169 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- FDL169
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2015to Mar 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male subjects aged 18 to 45 years who fulfil standard safety screening assessments for the study (haematology/biochemistry, urinalysis, 12-lead electrocardiogram (ECG), vital signs and oral temperature) and who in the opinion of the Investigator, are medically suitable to participate in the study. Male subjects and their partners 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.
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 history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (endocrine or immunologic disease), at Screening.
- Donation of 500 mL or more blood within the previous 3 months.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 21 days (or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Flatley Discovery Labs Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Smoking or use tobacco products or substitutes equivalent to > 15 cigarettes/day.
- Any subject attempting to father a child within 3 months of their Follow-Up Visit.
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 1, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation First-Time-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
To determine the safety and tolerability of single and multiple escalating doses of FDL169 in healthy male subjects.
Read the detailed description
This study is the first time in human study and consists of two parts.
Part 1A:
Part 1 of the study is a randomised, double-blind, placebo-controlled, dose-escalation, first-time-in-human study to assess the safety, tolerability and PK profiles following single oral administrations of FDL169 to healthy male volunteers. Sixty-four (64) male subjects (8 per cohort) will be included in Part 1 of the study. Up to eight dose levels of FDL169 are planned to be tested in Part 1 of the study.
Part 1B:
Open label. Following completion of Part 1A of the study, an additional cohort of 8 subjects will receive a single dose of FDL169 in both fasted and fed states
Part 2:
Part 2 of the study is a randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK profiles following multiple oral administrations of FDL169 to healthy male subjects. Forty-eight male subjects, in cohorts of twelve, will be included in Part 2 of the study. It is planned to test up to four dose levels of FDL169 in Part 2.
- Conditions
- Cystic Fibrosis
- Being tested
- FDL169, Placebo
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Placebo single dose | Placebo comparator | Placebo administered as a single dose Receives: Drug: Placebo |
| 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 |
| Single dose (Dose level 6) | Experimental | FDL169 (Dose level 6) administered as a single dose Receives: Drug: FDL169 |
| Single dose (Dose level 7) | Experimental | FDL169 (Dose level 7) administered as a single dose Receives: Drug: FDL169 |
| Single dose (Dose level 8) | Experimental | FDL169 (Dose level 8) administered as a single dose Receives: Drug: FDL169 |
| Additional single dose 1 | Experimental | Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) Receives: Drug: FDL169 |
| Additional single dose 2 | Experimental | Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) Receives: Drug: FDL169 |
| Additional single dose 3 | Experimental | Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) Receives: Drug: FDL169 |
| Additional single dose 4 | Experimental | Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) Receives: Drug: FDL169 |
| Food effect - fasted | Experimental | Single dose of FDL169 in fasted conditions Receives: Drug: FDL169 |
| Food effect - fed | Experimental | Single dose of FDL169 in fed conditions Receives: Drug: FDL169 |
| Placebo - multiple dose | Placebo comparator | Repeat doses of placebo Receives: Drug: Placebo |
| Multiple dose - Dose level 1 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) Receives: Drug: FDL169 |
| Multiple dose - Dose level 2 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) Receives: Drug: FDL169 |
| Multiple dose - Dose level 3 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) Receives: Drug: FDL169 |
| Multiple dose - Dose level 4 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) Receives: Drug: FDL169 |
| Multiple dose - additional dose level 1 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) Receives: Drug: FDL169 |
| Multiple dose - additional dose level 2 | Experimental | Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) Receives: Drug: FDL169 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1A: safety and tolerability for 48 h following single oral doses of FDL169 (Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)
Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)
Measured: Multiple points from screening to follow-up (up to 28 days)
Part 1B: food effect on the tolerability of FDL169 for 48 h following a single dose
Vital signs, ECG, safety laboratory data and AEs
Measured: Multiple points from screening to follow-up (up to 42 days)
Part 2: safety and tolerability following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose) (Vital signs, ECG, safety laboratory data and AEs)
Vital signs, ECG, safety laboratory data and AEs
Measured: Multiple points from screening to follow-up (up to 42 days)
Part 1B: food effect on the pharmacokinetics of FDL169 for 48 h following a single dose
Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated
Measured: Multiple points from pre-dose to 48 h post-dose
Secondary outcomes (2)
Part 1: pharmacokinetic profile for 48 h following single oral doses of FDL169
Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated
Measured: Multiple points from pre-dose to 48 h post-dose
Part 2: pharmacokinetic profile following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose)
Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated
Measured: Multiple points from pre-dose to 24 h post-dosing on Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2016
- Study completionMar 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Flatley Discovery Lab LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salvatore Febbraro, MD, Principal investigator, Simbec Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02359357
- Sponsor's protocol ID
- FDL169-2014-01
- Other IDs
- RD 674/25728
- Status last verified
- Apr 2016
- First submitted
- 13 Jan 2015
- Last updated
- 8 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation First-Time-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeat Oral Doses of FDL169 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02359357
- Acronym / sponsor ID
- FDL169-2014-01
- Conditions
- Cystic Fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Flatley Discovery Lab LLCUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 10 Feb 2015 (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 safety and tolerability of single and multiple escalating doses of FDL169 in healthy male subjects.
Detailed description
This study is the first time in human study and consists of two parts.
Part 1A:
Part 1 of the study is a randomised, double-blind, placebo-controlled, dose-escalation, first-time-in-human study to assess the safety, tolerability and PK profiles following single oral administrations of FDL169 to healthy male volunteers. Sixty-four (64) male subjects (8 per cohort) will be included in Part 1 of the study. Up to eight dose levels of FDL169 are planned to be tested in Part 1 of the study.
Part 1B:
Open label. Following completion of Part 1A of the study, an additional cohort of 8 subjects will receive a single dose of FDL169 in both fasted and fed states
Part 2:
Part 2 of the study is a randomised, double-blind, placebo-controlled, dose-escalation study to assess the safety, tolerability and PK profiles following multiple oral administrations of FDL169 to healthy male subjects. Forty-eight male subjects, in cohorts of twelve, will be included in Part 2 of the study. It is planned to test up to four dose levels of FDL169 in Part 2.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 22
| Arm | Type | Receives |
|---|---|---|
| Placebo single dose | Placebo comparator | Drug: PlaceboPlacebo administered as a single dose |
| 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 |
| Single dose (Dose level 6) | Experimental | Drug: FDL169FDL169 (Dose level 6) administered as a single dose |
| Single dose (Dose level 7) | Experimental | Drug: FDL169FDL169 (Dose level 7) administered as a single dose |
| Single dose (Dose level 8) | Experimental | Drug: FDL169FDL169 (Dose level 8) administered as a single dose |
| Additional single dose 1 | Experimental | Drug: FDL169Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
| Additional single dose 2 | Experimental | Drug: FDL169Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
| Additional single dose 3 | Experimental | Drug: FDL169Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
| Additional single dose 4 | Experimental | Drug: FDL169Single dose of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
| Food effect - fasted | Experimental | Drug: FDL169Single dose of FDL169 in fasted conditions |
| Food effect - fed | Experimental | Drug: FDL169Single dose of FDL169 in fed conditions |
| Placebo - multiple dose | Placebo comparator | Drug: PlaceboRepeat doses of placebo |
| Multiple dose - Dose level 1 | Experimental | Drug: FDL169Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
| Multiple dose - Dose level 2 | Experimental | Drug: FDL169Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
| Multiple dose - Dose level 3 | Experimental | Drug: FDL169Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
| Multiple dose - Dose level 4 | Experimental | Drug: FDL169Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
| Multiple dose - additional dose level 1 | Experimental | Drug: FDL169Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
| Multiple dose - additional dose level 2 | Experimental | Drug: FDL169Repeat doses of FDL169 to be administered at a dose level to be determined (up to Dose level 8) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male subjects aged 18 to 45 years who fulfil standard safety screening assessments for the study (haematology/biochemistry, urinalysis, 12-lead electrocardiogram (ECG), vital signs and oral temperature) and who in the opinion of the Investigator, are medically suitable to participate in the study. Male subjects and their partners 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.
Key exclusion criteria (6 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 history or presence of clinically significant cardiovascular, pulmonary, renal, hepatic, haematologic, gastrointestinal (endocrine or immunologic disease), at Screening.
- Donation of 500 mL or more blood within the previous 3 months.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 21 days (or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and Flatley Discovery Labs Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Smoking or use tobacco products or substitutes equivalent to > 15 cigarettes/day.
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 | Additional single dose 1, Additional single dose 2, Additional single dose 3, Additional single dose 4, Food effect - fasted, Food effect - fed, Multiple dose - Dose level 1, Multiple dose - Dose level 2, Multiple dose - Dose level 3, Multiple dose - Dose level 4, Multiple dose - additional dose level 1, Multiple dose - additional dose level 2, 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), Single dose (Dose level 6), Single dose (Dose level 7), Single dose (Dose level 8) |
| Placebo | Drug | Placebo - multiple dose, Placebo single dose |
Primary outcome
Part 1A: safety and tolerability for 48 h following single oral doses of FDL169 (Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)
Time frame: Multiple points from screening to follow-up (up to 28 days)
Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs)
Part 1B: food effect on the tolerability of FDL169 for 48 h following a single dose
Time frame: Multiple points from screening to follow-up (up to 42 days)
Vital signs, ECG, safety laboratory data and AEs
Part 2: safety and tolerability following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose) (Vital signs, ECG, safety laboratory data and AEs)
Time frame: Multiple points from screening to follow-up (up to 42 days)
Vital signs, ECG, safety laboratory data and AEs
Part 1B: food effect on the pharmacokinetics of FDL169 for 48 h following a single dose
Time frame: Multiple points from pre-dose to 48 h post-dose
Pharmacokinetic parameters: Cmax, tmax, lambdaz, t1/2, AUC(0-t), AUC(0-tau), AUC (0-inf) CL/F and AUC%extrapolated
2 secondary outcomes
Part 1: pharmacokinetic profile for 48 h following single oral doses of FDL169
Time frame: Multiple points from pre-dose to 48 h post-dose
Part 2: pharmacokinetic profile following multiple oral doses of FDL169 (assessed throughout dosing and for 24 h post-final dose)
Time frame: Multiple points from pre-dose to 24 h post-dosing on Day 14
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 8 Apr 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.
Salvatore Febbraro, MD 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 1 inclusion and 6 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 8 Apr 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. 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 1A: safety and tolerability for 48 h following single oral doses of FDL169 (Vital signs, electrocardiogram (ECG), safety laboratory data and adverse events (AEs) (time frame: Multiple points from screening to follow-up (up to 28 days)). The study lists 4 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 8 Apr 2016.