Chronic Renal InsufficiencyPhase 1NCT01846468
An Ascending Dose Study to Assess Safety, Tolerability, PK/PD of LHW090 in Healthy Volunteers and in Subjects With Renal Dysfunction
A Phase 1 study testing LHW090 in people with Chronic Renal Insufficiency, run by Novartis Pharmaceuticals at 2 sites in United States.
Trial summary
The purpose of the study is to provide pertinent information to enable decisions regarding the developability of LHW090 for use in patients with chronic renal insufficiency, including a comparison of the potential risk-benefit ratio of several doses of the study drug to enable optimal doses to be tested in later… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Renal Insufficiency
- What is being tested?
- LHW090
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 205 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Mar 2013to 28 Jun 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects eligible for inclusion in these stages of the study have to fulfill all of the following criteria at screening:
- Healthy male and female subjects age 18 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- At screening, and first baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes, and again (when required) after three minutes in the standing position. Sitting vital signs should be within the following ranges:
- oral body temperature between 35.0-37.5 °C systolic blood pressure, 90-140 mm Hg diastolic blood pressure, 50-90 mm Hg pulse rate, 40 - 90 bpm
- For Stage 4 subjects only:
- Male and female subjects, age 18 to 75 years of age included, with previously identified chronic renal insufficiency (estimated or measured GFR ≤ 45ml/min/1.73m2, or diabetic with estimated or measured GFR ≤ 60ml/min/1.73m2.) Diabetes can be established by the prescription and current use of anti-glycemic drugs, a random fasting glucose level of ≥ 144mg/dl or a hemoglobin A1c of ≥ 6.5%
- At screening, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes, and again (when required) after three minutes in the standing position. Sitting vital signs should be within the following ranges:
- oral body temperature between 35.0-37.5 °C systolic blood pressure, 90-179 mm Hg diastolic blood pressure, 50-100 mm Hg pulse rate, 40 - 95 bpm
Who cannot join
- For Stages 1, 2 and 3, subjects fulfilling any of the following additional criteria are not eligible for inclusion in this study:
- An active history of clinically significant ECG abnormalities as determined by the Investigator, or any of the following ECG abnormalities at Screening or Baseline:
- Long QT syndrome
- QTcF > 450 msec (males; at screening)
- QTcF > 460 msec (females; at screening)
- Known history of current clinically significant arrhythmias.
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- Use of phosphodiesterase-5 inhibitors, UNLESS subjects agree to discontinue use of the drug for the duration of the study.
- 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.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
- Smokers (use of tobacco products in the previous 3 months). Urine cotinine levels will be measured during screening and at each baseline for all subjects. Smokers will be defined as any subject who reports tobacco use and/or who has a urine cotinine ≥ 500 ng/ml.
- Hemoglobin levels below 11.0 g/dl at screening.
- Subjects in Stage 3 only of the study will be excluded if they have any of the following:
- A history of allergy to topical anesthetic drops
- A history of corneal disease
- A history of eye surgery within three months prior to screening
- A history of corneal surgery (including refractive surgery and corneal transplantation)
- For Stage 4, subjects fulfilling any of the following additional criteria are not eligible for inclusion in this study:
- An active history of clinically significant ECG abnormalities as determined by the Investigator, or any of the following ECG abnormalities at Screening or Baseline:
- Long QT syndrome
- QTcF > 480 msec at screening
- Use of phosphodiesterase-5 inhibitors, UNLESS subjects agree to discontinue use of the drug for the duration of the study.
- 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.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
- Significant smokers. Significant smokers who are unable to tolerate using no more than 4 cigarettes a day should be excluded
- History of right ventricular dysfunction within the last 12 months
- Hemoglobin levels below 9.0 g/dl at screening.
- Use of angiotensin converting enzyme inhibitors (ACEi), UNLESS subjects agree to either a withholding of their ACEi, or a switch to an angiotension receptor blocker, starting 5 days (or 5 half-lives which ever is longer) prior to initiation of study and extending to the end-of-study visit. Patient who withhold their ACEi for the specified duration must first consult with their primary physician to determine their suitability and safety for this temporary withholding of ACEi.
- Diuretic-dependence, i.e. unable to produce urine without diuretics, or at high risk of flash pulmonary edema without diuretics. Use of diuretics will exclude subjects UNLESS subjects agree to withhold diuretics starting the day prior to check-in and extending to discharge. Consultation of the subject with their primary physician must be used to determine their suitability and safety for temporary withholding of their diuretics.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Novartis Investigative Site
Knoxville, Tennessee, 37920
Novartis Investigative Site
Orlando, Florida, 32809
About this study
Official title: A Partially-blinded, Randomized, Placebo-controlled, Adaptive Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LHW090 in Healthy Volunteers and in Subjects With Renal Dysfunction
The purpose of the study is to provide pertinent information to enable decisions regarding the developability of LHW090 for use in patients with chronic renal insufficiency, including a comparison of the potential risk-benefit ratio of several doses of the study drug to enable optimal doses to be tested in later studies.
- Conditions
- Chronic Renal Insufficiency
- Being tested
- LHW090, Placebo
- Keywords
- Healthy volunteers and patients,, renal insufficiency,
- Medical subject headings
- Renal Insufficiency, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LHW090Drug
1 mg, 12.5 mg, 100 mg capsules
PlaceboDrug
Matching placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Stage 1 : LHW090, Healthy Volunteers | Experimental | Healthy Volunteers will receive single dose of LHW090 on Day 1. Receives: Drug: LHW090 |
| Stage 2: LHW090, Healthy Volunteer | Experimental | Healthy Volunteers across 7 single ascending dose cohorts will be administered LHW090 or matching placebo day 1 Receives: Drug: LHW090; Drug: Placebo |
| Stage 3: LHW090, Healthy Volunteer | Experimental | Healthy Volunteers across 6 multiple ascending dose cohorts will be administered LHW090 or matching placebo for 14 days. Receives: Drug: LHW090; Drug: Placebo |
| Stage 4: LHW090, Patients | Experimental | Subjects with Chronic Renal Insufficiency across 3 cohorts will be administered a single dose of LHW090 in Day 1. Receives: Drug: LHW090 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants (Healthy Volunteers) with reported adverse events receiving single oral dose of LHW090 as assessment of safety and tolerabiility
In this analysis AE and SAE will be reported
Measured: 6 months
Number of participants (Healthy Volunteers) with reported adverse events receiving multiple oral dose of LHW090 as assessment of safety and tolerabiility
In this analysis AE and SAE will be reported
Measured: 6 months
Number of participants (patients) with reported adverse events receiving single oral dose of LHW090 as assessment of safety and tolerabiility
In this analysis AE and SAE will be reported
Measured: 6 months
Secondary outcomes (13)
Pharmacokinetics of LHW090/LHV527 in plasma: observe maximum plasma concentration following LHW090 at steady state in healthy volunteers and patients
In this analysis Cmax will be reported
Measured: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: time to reach the maximum concentration after administration of LHW090 (Tmax)
In this analysis Tmax will be reported
Measured: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast)
In this analysis AUClast will be reported
Measured: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: area under the plasma concentration-time curve from time zero to infinity (AUCinf)
In this analysis AUCinf will be reported
Measured: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: terminal elimination half-life (T1/2)
In this analysis T1/2 will be reported
Measured: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: accumulation ratio (RACC)
In this analysis the accumulation ratio will be reported
Measured: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: apparent volume of distribution during the terminal elimination phase following extravascular administration (Vd/F)
In this analysis apparent volume of distribution during the terminal elimination phase will be reported
Measured: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: apparent system clearance from plasma following intravenous administration of iothalamate (CL/F)
In this analysis the apparent system clearance from plasma will be reported
Measured: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in urine: apparent system clearance from urine from time 0 - 24 hrs following drug administration (Ae0-24)
In this analysis the apparent system clearance by urine will be reported from 0 - 24 hrs post dose
Measured: Stage 1, 2 and 4 :0-4, 4-8, 8-12, 12-24, 24-36, 36-48 and 48 - 72 h post dose in Day 1 and Day 14; Stage 3: 0-4, 4-8, 8-12, and 12-24 h post dose
Pharmacokinetics of LHW090/LHV527 in urine: apparent system clearance from urine from time 0 - 72 hrs following drug administration (Ae0-72h)
In this analysis the apparent system clearance by urine will be reported from 0 - 72 hrs post dose
Measured: Stage 1, 2 and 4 :0-4, 4-8, 8-12, 12-24, 24-36, 36-48 and 48 - 72 h post dose in Day 1 and Day 14; Stage 3: 0-4, 4-8, 8-12, and 12-24 h post dose
Pharmacokinetics of LHW090/LHV527 in urine: apparent renal clearance from urine following drug administration (CLr)
In this analysis the apparent system clearance by urine will be reported
Measured: Stage 1, 2 and 4 :0-4, 4-8, 8-12, 12-24, 24-36, 36-48 and 48 - 72 h post dose in Day 1 and Day 14; Stage 3: 0-4, 4-8, 8-12, and 12-24 h post dose
Pharmacodynamics of LHW090/LHV527 in serum: post treatment peak and mean area under the plasma concentration-time curve from time zero to 24 hour (AUC0-24h/24h) for cyclic guanosine (cGMP)
In this analysis AUC0-24/24h will be reported for single ascending dose healthy volunteers and CRI subjects
Measured: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacodynamics of LHW090/LHV527 in serum: post treatment peak and mean area under the plasma concentration-time curve from time zero to 24 hour (AUC0-24h/24h) for atrial natriuretic peptide (ANP)
In this analysis AUC0-24/24h will be reported for single ascending dose healthy volunteers and CRI subjects
Measured: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study start1 Mar 2013
- Primary completion28 Jun 2014
- Study completion28 Jun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal InsufficiencyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 205 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
- NCT01846468
- Sponsor's protocol ID
- CLHW090X2101
- Status last verified
- Feb 2017
- First submitted
- 1 May 2013
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Partially-blinded, Randomized, Placebo-controlled, Adaptive Single and Multiple Ascending Dose Study to Assess Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LHW090 in Healthy Volunteers and in Subjects With Renal Dysfunction
- ClinicalTrials.gov ID
- NCT01846468
- Acronym / sponsor ID
- CLHW090X2101
- Conditions
- Chronic Renal Insufficiency
- Keywords
- Healthy volunteers and patients,, renal insufficiency,
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2013 (actual)
- Primary completion
- 28 Jun 2014 (actual)
- Study completion
- 28 Jun 2014 (actual)
- First posted
- 3 May 2013 (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.
The purpose of the study is to provide pertinent information to enable decisions regarding the developability of LHW090 for use in patients with chronic renal insufficiency, including a comparison of the potential risk-benefit ratio of several doses of the study drug to enable optimal doses to be tested in later studies.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stage 1 : LHW090, Healthy Volunteers | Experimental | Drug: LHW090Healthy Volunteers will receive single dose of LHW090 on Day 1. |
| Stage 2: LHW090, Healthy Volunteer | Experimental | Drug: LHW090, Drug: PlaceboHealthy Volunteers across 7 single ascending dose cohorts will be administered LHW090 or matching placebo day 1 |
| Stage 3: LHW090, Healthy Volunteer | Experimental | Drug: LHW090, Drug: PlaceboHealthy Volunteers across 6 multiple ascending dose cohorts will be administered LHW090 or matching placebo for 14 days. |
| Stage 4: LHW090, Patients | Experimental | Drug: LHW090Subjects with Chronic Renal Insufficiency across 3 cohorts will be administered a single dose of LHW090 in Day 1. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects eligible for inclusion in these stages of the study have to fulfill all of the following criteria at screening:
- Healthy male and female subjects age 18 to 45 years of age included, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening.
- At screening, and first baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed in the sitting position after the subject has rested for at least three minutes, and again (when required) after three minutes in the standing position. Sitting vital signs should be within the following ranges:
- oral body temperature between 35.0-37.5 °C systolic blood pressure, 90-140 mm Hg diastolic blood pressure, 50-90 mm Hg pulse rate, 40 - 90 bpm
- Male and female subjects, age 18 to 75 years of age included, with previously identified chronic renal insufficiency (estimated or measured GFR ≤ 45ml/min/1.73m2, or diabetic with estimated or measured GFR ≤ 60ml/min/1.73m2.) Diabetes can be established by the prescription and current use of anti-glycemic drugs, a random fasting glucose level of ≥ 144mg/dl or a hemoglobin A1c of ≥ 6.5%
Key exclusion criteria (28 listed)
- For Stages 1, 2 and 3, subjects fulfilling any of the following additional criteria are not eligible for inclusion in this study:
- An active history of clinically significant ECG abnormalities as determined by the Investigator, or any of the following ECG abnormalities at Screening or Baseline:
- Long QT syndrome
- QTcF > 450 msec (males; at screening)
- QTcF > 460 msec (females; at screening)
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 |
|---|---|---|
| LHW0901 mg, 12.5 mg, 100 mg capsules | Drug | Stage 1 : LHW090, Healthy Volunteers, Stage 2: LHW090, Healthy Volunteer, Stage 3: LHW090, Healthy Volunteer, Stage 4: LHW090, Patients |
| PlaceboMatching placebo capsules | Drug | Stage 2: LHW090, Healthy Volunteer, Stage 3: LHW090, Healthy Volunteer |
Primary outcome
Number of participants (Healthy Volunteers) with reported adverse events receiving single oral dose of LHW090 as assessment of safety and tolerabiility
Time frame: 6 months
In this analysis AE and SAE will be reported
Number of participants (Healthy Volunteers) with reported adverse events receiving multiple oral dose of LHW090 as assessment of safety and tolerabiility
Time frame: 6 months
In this analysis AE and SAE will be reported
Number of participants (patients) with reported adverse events receiving single oral dose of LHW090 as assessment of safety and tolerabiility
Time frame: 6 months
In this analysis AE and SAE will be reported
13 secondary outcomes
Pharmacokinetics of LHW090/LHV527 in plasma: observe maximum plasma concentration following LHW090 at steady state in healthy volunteers and patients
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: time to reach the maximum concentration after administration of LHW090 (Tmax)
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (AUClast)
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: area under the plasma concentration-time curve from time zero to infinity (AUCinf)
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: terminal elimination half-life (T1/2)
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: accumulation ratio (RACC)
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: apparent volume of distribution during the terminal elimination phase following extravascular administration (Vd/F)
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in plasma: apparent system clearance from plasma following intravenous administration of iothalamate (CL/F)
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacokinetics of LHW090/LHV527 in urine: apparent system clearance from urine from time 0 - 24 hrs following drug administration (Ae0-24)
Time frame: Stage 1, 2 and 4 :0-4, 4-8, 8-12, 12-24, 24-36, 36-48 and 48 - 72 h post dose in Day 1 and Day 14; Stage 3: 0-4, 4-8, 8-12, and 12-24 h post dose
Pharmacokinetics of LHW090/LHV527 in urine: apparent system clearance from urine from time 0 - 72 hrs following drug administration (Ae0-72h)
Time frame: Stage 1, 2 and 4 :0-4, 4-8, 8-12, 12-24, 24-36, 36-48 and 48 - 72 h post dose in Day 1 and Day 14; Stage 3: 0-4, 4-8, 8-12, and 12-24 h post dose
Pharmacokinetics of LHW090/LHV527 in urine: apparent renal clearance from urine following drug administration (CLr)
Time frame: Stage 1, 2 and 4 :0-4, 4-8, 8-12, 12-24, 24-36, 36-48 and 48 - 72 h post dose in Day 1 and Day 14; Stage 3: 0-4, 4-8, 8-12, and 12-24 h post dose
Pharmacodynamics of LHW090/LHV527 in serum: post treatment peak and mean area under the plasma concentration-time curve from time zero to 24 hour (AUC0-24h/24h) for cyclic guanosine (cGMP)
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
Pharmacodynamics of LHW090/LHV527 in serum: post treatment peak and mean area under the plasma concentration-time curve from time zero to 24 hour (AUC0-24h/24h) for atrial natriuretic peptide (ANP)
Time frame: Within 60 min prior to dosing, post dose: +/- 5 min up to 3 hrs, +/- 10 min from ≥3 hrs to 24hrs, +/- 2 hrs from ≥24 hrs to 72hrs
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 17 Dec 2020.
- Results for CCLHW090X2101 can be found on the Novartis Clinical Trial Results WebsiteLink provided by the sponsor.
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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
2 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 LHW090 in people with Chronic Renal Insufficiency, run by Novartis Pharmaceuticals at 2 sites 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 8 inclusion and 28 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 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
Number of participants (Healthy Volunteers) with reported adverse events receiving single oral dose of LHW090 as assessment of safety and tolerabiility (time frame: 6 months). The study lists 3 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 17 Dec 2020.