Pharmacokinetics of FDL169 in Healthy Female Subjects

March 29, 2016 updated by: Flatley Discovery Lab LLC

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
8

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Wales
      • Merthyr Tydfil, Wales, United Kingdom, CF48 4DR
        • Simbec Research Ltd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 51 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. 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)]
  2. 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).

Exclusion Criteria:

  1. Participation in a New Chemical Entity clinical study within the previous 4 months or a marketed drug clinical study within the previous 3 months.
  2. Subjects who have any renal or clinically significant cardiac, renal or hepatic disease at Screening.
  3. 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.
  4. 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.
  5. Subjects with a positive urinary drugs of abuse screen or positive alcohol screen at Screening or Day -1.
  6. History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of > 21 units.
  7. Subject with history of HIV or positive human immunodeficiency virus, hepatitis B or hepatitis C results.
  8. Donation of 500 mL or more of blood within the previous 3 months.
  9. 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.
  10. Smoking or use of tobacco products or substitutes equivalent to > 15 cigarettes/day.
  11. Any subject who is pregnant or nursing.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single dose (Dose level 1)
FDL169 (Dose level 1) administered as a single dose
Drug: FDL169
Experimental: Single dose (Dose level 2)
FDL169 (Dose level 2) administered as a single dose
Drug: FDL169
Experimental: Single dose (Dose level 3)
FDL169 (Dose level 3) administered as a single dose
Drug: FDL169
Experimental: Single dose (Dose level 4)
FDL169 (Dose level 4) administered as a single dose
Drug: FDL169
Experimental: Single dose (Dose level 5)
FDL169 (Dose level 5) administered as a single dose
Drug: FDL169
Experimental: Multiple dose
Repeat doses of FDL169 to be administered at a dose level to be determined
Drug: FDL169

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Multiple points from pre-dose to 48 h post-final dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
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
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
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
Multiple points from pre-dose to 48 h post (last) dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Flatley Discovery Lab LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Khalid Abou-Farha, MBChB MD PhD, Simbec Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 11, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 31, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FDL169-2015-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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