Part 1 - Healthy VolunteersPhase 1NCT02047656
To Evaluate Pharmacokinetics of LFF269 in Healthy Volunteers and Patients With Hypertension
A Phase 1 study testing LFF269 in people with Part 1 - Healthy Volunteers and Part 2 - Patients With Hypertension, run by Novartis Pharmaceuticals at 1 site in United States.
Trial summary
This study is designed to enable optimal dose selection of LFF269 for potential future studies by providing additional information about the compounds safety, tolerability, pharmacokinetic and pharmacodynamic profiles. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Part 1 - Healthy Volunteers, Part 2 - Patients With Hypertension
- What is being tested?
- LFF269
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Aug 2014
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part 1
- Healthy men and women of non-childbearing potential, 18 to 80 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Part 2
- Hypertensive men and women of non-childbearing potential, 18 to 80 years of age inclusive.
- Patients with mild-to-moderate uncomplicated essential hypertension
Who cannot join
- Part 1
- History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes.
- A history of clinically significant ECG abnormalities.
- Known history or current clinically significant arrhythmias.
- History of hypertension, adrenal or endocrine disease.
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
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- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant.
- Smokers (use of tobacco products in the previous 3 months).
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- A positive Hepatitis B surface antigen or Hepatitis C test result.
- Part 2
- Pregnant or nursing (lactating) women.
- Women of child-bearing potential.
- Known history or evidence of a secondary form of hypertension
- Type 1 or type 2 diabetes mellitus.
- History of heart diseases
- A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
- History of immunodeficiency diseases, including a positive HIV (ELISA and Western blot) test result.
- Other protocol defined inclusion/exclusion criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Two Part Study Including a Randomized, Double Blind, Placebo Controlled, Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LFF269 After b.i.d Dosing in Healthy Volunteers and an Open Label, Multiple Dose Pharmacokinetics Study in Hypertension Subjects
This study is designed to enable optimal dose selection of LFF269 for potential future studies by providing additional information about the compounds safety, tolerability, pharmacokinetic and pharmacodynamic profiles.
- Being tested
- LFF269, Placebo to LFF269
- Keywords
- Healthy volunteers, hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFF269Drug
Also called LFF269 active
LFF269 capsules twice daily (b.i.d)
Placebo to LFF269Drug
Also called placebo
Placebo LFF269 b.i.d for 10 days in healthy volunteers
| Study group | Role | What they receive |
|---|---|---|
| Placebo to LFF269 (Part 1) | Placebo comparator | Placebo to LFF269 twice daily (b.i.d) for 10 days in healthy volunteers Receives: Drug: Placebo to LFF269 |
| LFF269 (Part 1) | Experimental | LFF269 twice daily (b.i.d) for 10 days in healthy volunteers Receives: Drug: LFF269 |
| LFF269 (Part 2) | Experimental | LFF269 twice daily (b.i.d) for 5 days in patients with hypertension Receives: Drug: LFF269 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of healthy volunteers reported with adverse events as an assessment of safety and tolerability (Part 1)
Measured: 10 days
Secondary outcomes (9)
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)[Part 1- Healthy volunteers]
Measured: Day 1
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 1- Healthy volunteers]
Measured: Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) [Part 2- Patients with hypertension]
Measured: Day 1
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 2 - Patients with hypertension]
Measured: Day 1
Area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) [Part 1- Healthy volunteers]
Measured: Day 10
Area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) [Part 2 - Patients with hypertension]
Measured: Day 5
Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 2 - Patients with hypertension]
Measured: Up to Day 5
Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 1- Healthy volunteers]
Measured: Up to Day 10
Number of patients reported with adverse events as an assessment of safety and tolerability (Part - 2, Patient with Hypertension)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2014 (estimated)
- Study startAug 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Part 1 - Healthy VolunteersStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02047656
- Sponsor's protocol ID
- CLFF269X2105
- Status last verified
- Mar 2016
- First submitted
- 26 Jan 2014
- Last updated
- 1 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Two Part Study Including a Randomized, Double Blind, Placebo Controlled, Multiple Dose Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LFF269 After b.i.d Dosing in Healthy Volunteers and an Open Label, Multiple Dose Pharmacokinetics Study in Hypertension Subjects
- ClinicalTrials.gov ID
- NCT02047656
- Acronym / sponsor ID
- CLFF269X2105
- Keywords
- Healthy volunteers, hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Jan 2014 (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.
This study is designed to enable optimal dose selection of LFF269 for potential future studies by providing additional information about the compounds safety, tolerability, pharmacokinetic and pharmacodynamic profiles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo to LFF269 (Part 1) | Placebo comparator | Drug: Placebo to LFF269Placebo to LFF269 twice daily (b.i.d) for 10 days in healthy volunteers |
| LFF269 (Part 1) | Experimental | Drug: LFF269LFF269 twice daily (b.i.d) for 10 days in healthy volunteers |
| LFF269 (Part 2) | Experimental | Drug: LFF269LFF269 twice daily (b.i.d) for 5 days in patients with hypertension |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Part 1
- Healthy men and women of non-childbearing potential, 18 to 80 years of age inclusive, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- Part 2
- Hypertensive men and women of non-childbearing potential, 18 to 80 years of age inclusive.
- Patients with mild-to-moderate uncomplicated essential hypertension
Key exclusion criteria (19 listed)
- Part 1
- History of hypersensitivity or allergy to any of the study drugs or to drugs of similar chemical classes.
- A history of clinically significant ECG abnormalities.
- Known history or current clinically significant arrhythmias.
- History of hypertension, adrenal or endocrine disease.
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 |
|---|---|---|
| LFF269Also: LFF269 activeLFF269 capsules twice daily (b.i.d) | Drug | LFF269 (Part 1), LFF269 (Part 2) |
| Placebo to LFF269Also: placeboPlacebo LFF269 b.i.d for 10 days in healthy volunteers | Drug | Placebo to LFF269 (Part 1) |
Primary outcome
Number of healthy volunteers reported with adverse events as an assessment of safety and tolerability (Part 1)
Time frame: 10 days
9 secondary outcomes
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau)[Part 1- Healthy volunteers]
Time frame: Day 1
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 1- Healthy volunteers]
Time frame: Day 1
Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau (AUCtau) [Part 2- Patients with hypertension]
Time frame: Day 1
Observed maximum plasma concentration following drug administration (Cmax) at day 1 [Part 2 - Patients with hypertension]
Time frame: Day 1
Area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) [Part 1- Healthy volunteers]
Time frame: Day 10
Area under the plasma concentration-time curve from time zero to the end of the dosing interval tau at steady state (AUCtau,ss) [Part 2 - Patients with hypertension]
Time frame: Day 5
Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 2 - Patients with hypertension]
Time frame: Up to Day 5
Observed maximum plasma concentration following drug administration at steady state (Cmax,ss) [Part 1- Healthy volunteers]
Time frame: Up to Day 10
Number of patients reported with adverse events as an assessment of safety and tolerability (Part - 2, Patient with Hypertension)
Time frame: 5 days
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
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 LFF269 in people with Part 1 - Healthy Volunteers and Part 2 - Patients With Hypertension, run by Novartis Pharmaceuticals at 1 site in United States.
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 5 inclusion and 19 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: stopped early, as of the sponsor's last update on 1 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 States. 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 was stopped early. Results are not available in the source record.
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?
Number of healthy volunteers reported with adverse events as an assessment of safety and tolerability (Part 1) (time frame: 10 days). 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 1 Apr 2016.