Effects of Different Meals on the QT/QTc IntervalPhase 1C11035NCT01642485

Food and Insulin Effect on QT/QTC Interval of ECG

A Phase 1 study testing Moxifloxacin 400 mg fasted, FDA breakfast and Continental breakfast in people with Effects of Different Meals on the QT/QTc Interval and Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, run by Richmond Pharmacology Limited at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Moxifloxacin is routinely used as a probe to confirm assay sensitivity in thorough electrocardiogram (ECG) studies. It has been shown that a meal shortens the QT interval, which may affect pharmacokinetics (PK) and/or pharmacodynamics (PD) of the study drug. However, there is no published data clarifying this issue. Read more about this study

Who is it for?: Ages 20 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval
What is being tested?: Moxifloxacin 400 mg fasted, FDA breakfast and Continental breakfast
Type of treatment: Pill or oral medicine, Injection or infusion, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 32 participants
Where: 1 siteUnited Kingdom
Study dates: Jul 2011to Sep 2011
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy male or female, 20 - 45 years old
Signed ICF
Japanese - a descendant of four Japanese grandparents, carrying a Japanese passport and has not been outside Japan for more than 5 years prior to screening
The Caucasian - light to brown skin pigmentation; straight to wavy or curly hair; indigenous to Europe, northern Africa, western Asia, and India. The study may also include Caucasians from North America, Australia and South Africa
No clinical findings on the physical examination
Body mass index (BMI) = 18 - 25 kg/m2, body weight at least 48 kg.

Show all 11Show fewer

Systolic blood pressure 90-145 mmHg, diastolic blood pressure 40-90 mmHg, and heart rate 40-90 bpm
Triplicate 12 lead ECG without clinically relevant abnormalities
24 hour 12 lead Holter ECG without clinically relevant abnormalities
Haematology, biochemistry and urinalysis within the normal range
Must agree to use acceptable methods of contraception

Who cannot join

History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug
History of clinically significant syncope.
Family history of sudden death.
Family history of premature cardiovascular death.
Family history of congenital long QT syndrome or Brugada's syndrome.
History of arrhythmias and ischemic heart disease

Show all 34Show fewer

Conditions predisposing to electrolyte imbalances (e.g. altered nutritional states, chronic vomiting, anorexia nervosa, bulimia nervosa).
Abnormal ECG in the standard 12-lead ECG and 24-hour 12 lead Holter ECG
Abnormal rhythm, conduction or morphology of resting ECG, such as:
Sinus node dysfunction.
Clinically significant PR (PQ) interval prolongation.
Intermittent second or third degree AV block.
Incomplete or complete bundle branch block.
Abnormal T wave morphology.
Prolonged QTcB >450 msec or shortened QTcB < 350 msec or family history of long QT syndrome.
Abnormal blood glucose result (blood glucose >7.8mmol/l)
Significant family history of diabetes mellitus.
Significantly elevated fasting blood glucose level
Signs and/or symptoms of acute illness in the four-week period prior to screening.
Veins unsuitable for intravenous puncture or cannulation on either arm
Known hypersensitivity to any medicines administered in the trial.
Treatment with any prescribed medication during the 2 weeks prior to first baseline day.
Treatment with any over-the-counter (OTC) medications during the 2 weeks prior to first baseline day.
Treatment with vitamins and/or minerals within 48 hours prior to the first baseline day.
Treatment with another investigational drug within 4 weeks prior to dosing or having participated in more than 3 investigational drug studies within a year prior to dosing.
Positive urine drug screen (amphetamines, benzodiazepines, cocaine, cannabinoids, opiates, barbiturates and methadone) or the alcohol breath test
History or clinical evidence of alcoholism (regular weekly alcohol intake of more than 14 units if female and 21 units if male) or drug abuse (compulsive, repetitive and/or chronic use of drugs or other substances with or without problems related to their use and/or where stopping or a reduction in dose will lead to withdrawal symptoms)
Excessive caffeine consumption (≥800 mg per day)
Smoking within 3 months prior to screening
Loss of 250 mL or more blood within 3 months prior to screening.
Positive results from the hepatitis serology, except for vaccinated subjects.
Positive results from the HIV serology.
Any circumstances or conditions, which may affect full participation in the study or compliance with the protocol.
Legal incapacity or limited legal capacity.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Richmond Pharmacology Ltd
London, Tooting, SW17 0RE

Other trials in United Kingdom

About this study

Official title: Evaluation of the Effect of Different Foods, Carbohydrate Meal, and a Euglycaemic Insulin Clamp on the QT/QTc Interval Using a Single Dose of Moxifloxacin as a Positive Control in Healthy Male and Female, Caucasian and Japanese Volunteers

The aims of the study were to compare the effect of different food contents to placebo on the changes in ECG and to demonstrate the effect of insulin, C-peptide and glucose on the ECG. This was done by giving different treatments on separate days, which included intravenous insulin, a high carbohydrate breakfast [>70%], and a calorie reduced low carbohydrate American FDA standard breakfast. Moxifloxacin 400 mg was used as a positive control and was given with and without food to Caucasian and Japanese volunteers to investigate racial differences.

Read the detailed description

This study was initially performed in 24 healthy Caucasian and Japanese volunteers with an option to increase the sample size to up to 54 volunteers. The decision to increase the sample size to 32 was based on the standard deviation of the ECG intervals observed in the first 24 volunteers. This analysis was performed by an independent statistician under blinded conditions.

Each volunteer participated in 2 periods. Each period consisted of 1 baseline day (D-1) followed by 3 study days (D1 - D3) when the various food effect and drug treatments or placebo were administered. All volunteers received all treatments. Moxifloxacin was always given on D3 to prevent any carryover effect and there was a minimum washout period of 3 days in between the 2 periods.

How well the treatments (insulin/glucose, high carbohydrate breakfast, calorie reduced breakfast and moxifloxacin) were tolerated by the volunteers was assessed and any side effects noted.

We compared the effects of the various treatments between Caucasian and Japanese volunteers.

Moxifloxacin and placebo were given to volunteers by mouth, i.e. they were asked to swallow them with water. The different types of breakfast were provided which volunteers were asked to eat. Insulin and glucose were administered intravenously (Insulin/glucose clamp). Hence, the study was performed as an open-label design.

This study was conducted as a single site study at Richmond Pharmacology/ St George's University of London.

Conditions: Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval, Moxifloxacin ECG Profile in Fed and Fasted State, Japanese vs. Caucasian TQT Comparison
Being tested: Moxifloxacin 400 mg fasted, FDA breakfast, Continental breakfast, Moxifloxacin 400 mg fed, Insulin Clamp
Keywords: Insulin clamp, Glucose clamp, Moxifloxacin, Fed, Fasted, QT/QTC interval, TQT, ECG, Meal effects, C Peptide, Japanese Caucasian bridging, TQT bridging, FDA standard breakfast, Adaptive study design
Medical subject headings: Insulin Resistance, Fasting, Lecithin Cholesterol Acyltransferase Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Moxifloxacin 400 mg fastedDrug
Also called Moxifloxacin
Subjects receiving drug (400 mg moxifloxacin),having fasted overnight for 10 hours.
This is the standard probe for the assessment of assay sensitivity in Thorough QT (TQT) studies.
FDA breakfastOther
Calorie reduced FDA standard breakfast (58% fat, low carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a lesser effect on QTc compared to a carbohydrate rich breakfast should be observed.
Continental breakfastOther
High carbohydrate breakfast (>70% carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a greater effect on QTc compared to a low carbohydrate breakfast (FDA standard breakfast) should be observed.
Moxifloxacin 400 mg fedDrug
Also called Moxifloxacin
Currently, there is no published data showing the effects of a single 400 mg oral dose of moxifloxacin on the ECG/QT/QTc after food.
Insulin ClampProcedure or surgery
A euglycaemic/hyperinsulinaemic clamp, (DeFronzo, 1979) involves acutely raising the plasma insulin levels to a steady state and maintaining a state of euglycaemia with a glucose infusion, thereby effectively stopping endogenous insulin and C-peptide release. This technique will confirm whether hyperinsulinaemia has any effect on the QT/QTc interval.
PlaceboDrug
Comparison of different meals effect on Moxifloxacin PK profile

Study groups in NCT01642485
Study group	Role	What they receive
Moxifloxacin 400 mg fasted	Active comparator	Moxifloxacin 400 mg fasted was administered on Day 3. For Day 1 and 2, there were 4 different sequences: Placebo and Insulin Clamp; Insulin Clamp and Continental breakfast; Continental breakfast and FDA breakfast; FDA breakfast and Placebo. Additionally, Caucasian vs Japanese subjects were analysed. Receives: Drug: Moxifloxacin 400 mg fasted; Other: FDA breakfast; Other: Continental breakfast; Procedure: Insulin Clamp; Drug: Placebo
Moxifloxacin 400 mg fed	Experimental	Moxifloxacin 400 mg fed was administered on Day 3 after Continental breakfast. For Day 1 and 2, there were 4 different sequences: Placebo and Insulin Clamp; Insulin Clamp and Continental breakfast; Continental breakfast and FDA breakfast; FDA breakfast and Placebo. Additionally, Caucasian vs Japanese subjects were analysed. Receives: Other: FDA breakfast; Other: Continental breakfast; Drug: Moxifloxacin 400 mg fed; Procedure: Insulin Clamp; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

The Effect of Food (Fasted and Fed State) on the Degree of QT Prolongation Caused by Moxifloxacin
The primary baseline corrections were calculated using averaged QTc baseline values (the mean of all median readings recorded for each time-point on the baseline Day -1). This single value (QTcbaselineAV) was used to calculate ΔQTc for each study period.
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose

Secondary outcomes (4)

The Food Effects (Calorie Reduced FDA Breakfast and Carbohydrate Rich Continental Style) on QTcF
Scott et al (2002) demonstrated an increase in the heart rate of 10bpm in some healthy subjects following ingestion of a carbohydrate meal. There was significant correlation between the resultant hyperinsulinaemia and an increase in skeletal muscle blood flow, and sympathetic activity, with a reduction in vascular resistance.
If postprandial insulinaemia is a significant influence on the QT interval, then carbohydrate rich meals would be expected to show greater effect. Therefore, to explore this on two separate days of the study subjects will be given one of two different types of breakfast:
1. A high carbohydrate content breakfast, (>70% carbohydrate)
2. A reduced calorie FDA standard breakfast, (58% fat, low carbohydrate content) to determine effect on QT interval.
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose
Moxifloxacin 400 mg (Single Dose) Compared to Placebo on the Mean QT/QTc Interval.
"Moxifloxacin 400mg Fasted" group is reporting the maximum change in QT/QTc interval from placebo treatment.
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose
Insulin, Glucose and C-Peptide Effects on the QT/QTc Interval
The effect on QTc was investigated using linear mixed effect models with placebo corrected QTcF (change from average baseline) as a dependent variable and insulin, glucose and C-peptide (placebo corrected) as covariates for the data obtained under the euglycaemic clamp as well as for all data obtained under the clamp and the two types of breakfast.
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose
The QTcF Profile of Oral Moxifloxacin (400 mg) in Healthy Japanese Versus Caucasian Subjects
Measured: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2011Sep 2011

First posted17 Jul 2012 (estimated)
Study startJul 2011
Primary completionSep 2011
Study completionSep 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Effects of Different Meals on the QT/QTc IntervalStudies 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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01642485
Sponsor's protocol ID: RPL-01-11
Other IDs: 2011-002423-17
Acronym: C11035
Status last verified: Aug 2014
First submitted: 19 Jun 2012
Last updated: 20 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Taubel J, Wong AH, Naseem A, Ferber G, Camm AJ. Shortening of the QT interval after food can be used to demonstrate assay sensitivity in thorough QT studies. J Clin Pharmacol. 2012 Oct;52(10):1558-65. doi: 10.1177/0091270011419851. Epub 2011 Nov 8.
PubMed 22067197
Scott EM, Greenwood JP, Vacca G, Stoker JB, Gilbey SG, Mary DA. Carbohydrate ingestion, with transient endogenous insulinaemia, produces both sympathetic activation and vasodilatation in normal humans. Clin Sci (Lond). 2002 May;102(5):523-9.
PubMed 11980571
DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
PubMed 382871
Taubel J, Ferber G, Lorch U, Batchvarov V, Savelieva I, Camm AJ. Thorough QT study of the effect of oral moxifloxacin on QTc interval in the fed and fasted state in healthy Japanese and Caucasian subjects. Br J Clin Pharmacol. 2014 Jan;77(1):170-9. doi: 10.1111/bcp.12168.
PubMed 23713767
Taubel J, Lorch U, Ferber G, Singh J, Batchvarov VN, Savelieva I, Camm AJ. Insulin at normal physiological levels does not prolong QT(c) interval in thorough QT studies performed in healthy volunteers. Br J Clin Pharmacol. 2013 Feb;75(2):392-403. doi: 10.1111/j.1365-2125.2012.04376.x.
PubMed 22775199

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effect of Different Foods, Carbohydrate Meal, and a Euglycaemic Insulin Clamp on the QT/QTc Interval Using a Single Dose of Moxifloxacin as a Positive Control in Healthy Male and Female, Caucasian and Japanese Volunteers
ClinicalTrials.gov ID: NCT01642485
Acronym / sponsor ID: C11035 / RPL-01-11
Conditions: Effects of Different Meals on the QT/QTc Interval, Insulin and Oral Hypoglycemic [Antidiabetic] Drugs Causing Adverse Effects in Therapeutic Use, C-Peptide Effects on the QT/QTc Interval, Moxifloxacin ECG Profile in Fed and Fasted State, Japanese vs. Caucasian TQT Comparison
Keywords: Insulin clamp, Glucose clamp, Moxifloxacin, Fed, Fasted, QT/QTC interval, TQT, ECG
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 32 participants (actual)
Lead sponsor: Richmond Pharmacology LimitedIndustry (pharma, biotech, devices)
Study start: Jul 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 17 Jul 2012 (estimated)
Results: Posted 20 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

How well the treatments (insulin/glucose, high carbohydrate breakfast, calorie reduced breakfast and moxifloxacin) were tolerated by the volunteers was assessed and any side effects noted.

We compared the effects of the various treatments between Caucasian and Japanese volunteers.

This study was conducted as a single site study at Richmond Pharmacology/ St George's University of London.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Moxifloxacin 400 mg fasted	Active comparator	Drug: Moxifloxacin 400 mg fasted, Other: FDA breakfast, Other: Continental breakfast, Procedure: Insulin Clamp, Drug: PlaceboMoxifloxacin 400 mg fasted was administered on Day 3. For Day 1 and 2, there were 4 different sequences: Placebo and Insulin Clamp; Insulin Clamp and Continental breakfast; Continental breakfast and FDA breakfast; FDA breakfast and Placebo. Additionally, Caucasian vs Japanese subjects were analysed.
Moxifloxacin 400 mg fed	Experimental	Other: FDA breakfast, Other: Continental breakfast, Drug: Moxifloxacin 400 mg fed, Procedure: Insulin Clamp, Drug: PlaceboMoxifloxacin 400 mg fed was administered on Day 3 after Continental breakfast. For Day 1 and 2, there were 4 different sequences: Placebo and Insulin Clamp; Insulin Clamp and Continental breakfast; Continental breakfast and FDA breakfast; FDA breakfast and Placebo. Additionally, Caucasian vs Japanese subjects were analysed.

Who may qualify

Ages: 20 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (11 listed)

Healthy male or female, 20 - 45 years old
Signed ICF
Japanese - a descendant of four Japanese grandparents, carrying a Japanese passport and has not been outside Japan for more than 5 years prior to screening
The Caucasian - light to brown skin pigmentation; straight to wavy or curly hair; indigenous to Europe, northern Africa, western Asia, and India. The study may also include Caucasians from North America, Australia and South Africa
No clinical findings on the physical examination

Key exclusion criteria (34 listed)

History or clinical evidence of any disease and/or existence of any surgical or medical condition which might interfere with the absorption, distribution, metabolism or excretion of the study drug
History of clinically significant syncope.
Family history of sudden death.
Family history of premature cardiovascular death.
Family history of congenital long QT syndrome or Brugada's syndrome.

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
Moxifloxacin 400 mg fastedAlso: MoxifloxacinSubjects receiving drug (400 mg moxifloxacin),having fasted overnight for 10 hours. This is the standard probe for the assessment of assay sensitivity in Thorough QT (TQT) studies.	Drug	Moxifloxacin 400 mg fasted
FDA breakfastCalorie reduced FDA standard breakfast (58% fat, low carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a lesser effect on QTc compared to a carbohydrate rich breakfast should be observed.	Other	Moxifloxacin 400 mg fasted, Moxifloxacin 400 mg fed
Continental breakfastHigh carbohydrate breakfast (>70% carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a greater effect on QTc compared to a low carbohydrate breakfast (FDA standard breakfast) should be observed.	Other	Moxifloxacin 400 mg fasted, Moxifloxacin 400 mg fed
Moxifloxacin 400 mg fedAlso: MoxifloxacinCurrently, there is no published data showing the effects of a single 400 mg oral dose of moxifloxacin on the ECG/QT/QTc after food.	Drug	Moxifloxacin 400 mg fed
Insulin ClampA euglycaemic/hyperinsulinaemic clamp, (DeFronzo, 1979) involves acutely raising the plasma insulin levels to a steady state and maintaining a state of euglycaemia with a glucose infusion, thereby effectively stopping endogenous insulin and C-peptide release. This technique will confirm whether hyperinsulinaemia has any effect on the QT/QTc interval.	Procedure or surgery	Moxifloxacin 400 mg fasted, Moxifloxacin 400 mg fed
PlaceboComparison of different meals effect on Moxifloxacin PK profile	Drug	Moxifloxacin 400 mg fasted, Moxifloxacin 400 mg fed

Primary outcome

The Effect of Food (Fasted and Fed State) on the Degree of QT Prolongation Caused by Moxifloxacin
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose
The primary baseline corrections were calculated using averaged QTc baseline values (the mean of all median readings recorded for each time-point on the baseline Day -1). This single value (QTcbaselineAV) was used to calculate ΔQTc for each study period.

4 secondary outcomes

The Food Effects (Calorie Reduced FDA Breakfast and Carbohydrate Rich Continental Style) on QTcF
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose
Moxifloxacin 400 mg (Single Dose) Compared to Placebo on the Mean QT/QTc Interval.
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose
Insulin, Glucose and C-Peptide Effects on the QT/QTc Interval
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose
The QTcF Profile of Oral Moxifloxacin (400 mg) in Healthy Japanese Versus Caucasian Subjects
Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose

Results and safety

Results posted to the registry on 20 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1	4	4
Sequence 2	4	4
Sequence 3	4	4
Sequence 4	4	4
Sequence 5	4	4
Sequence 6	4	4
Sequence 7	4	4
Sequence 8	4	4

Primary outcome: The Effect of Food (Fasted and Fed State) on the Degree of QT Prolongation Caused by Moxifloxacin

Time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose. Mean (90% Confidence Interval). Unit: ms

Measure	Fasted Group n = 32	Fed Group n = 32
Value	14.4 (11.9 to 16.8)	11.6 (9.1 to 14.1)

Fasted Group: p = 0.05, t-test, 1 sided

Population analysed: Since the baseline was used as a covariate in the analysis, using the standard deviation of the change from baseline, in the simple sample size formula is justified. Assuming a standard deviation of 7 msec for the single differences, sample sizes for the sum can therefore work with a standard deviation of 6.5 msec.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: The AEs were recorded at screening: Days: -21 to -3, daily through Period 1 (from Day -2 to Day 3), washout period (3 days), daily through Period 2 (from Day -2 to Day 3) and at follow-up visit (7-14 days after the end of Period 2).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Moxifloxacin 400 mg Fasted	0 of 32 (0%)	0 of 32 (0%)	Not reported
Moxifloxacin 400 mg Fed	0 of 32 (0%)	0 of 32 (0%)	Not reported

Limitations and caveats (from the sponsor): Our findings based on the confirmatory and concentration-effect analysis suggest that any difference between ethnicities was most likely attributable to differences in plasma concentrations and not differences in sensitivity to moxifloxacin.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22067197Taubel J, Wong AH, Naseem A, Ferber G, Camm AJ. Shortening of the QT interval after food can be used to demonstrate assay sensitivity in thorough QT studies. J Clin Pharmacol. 2012 Oct;52(10):1558-65. doi: 10.1177/0091270011419851. Epub 2011 Nov 8.
Background: PubMed 11980571Scott EM, Greenwood JP, Vacca G, Stoker JB, Gilbey SG, Mary DA. Carbohydrate ingestion, with transient endogenous insulinaemia, produces both sympathetic activation and vasodilatation in normal humans. Clin Sci (Lond). 2002 May;102(5):523-9.
Background: PubMed 382871DeFronzo RA, Tobin JD, Andres R. Glucose clamp technique: a method for quantifying insulin secretion and resistance. Am J Physiol. 1979 Sep;237(3):E214-23. doi: 10.1152/ajpendo.1979.237.3.E214.
Results publication: PubMed 23713767Taubel J, Ferber G, Lorch U, Batchvarov V, Savelieva I, Camm AJ. Thorough QT study of the effect of oral moxifloxacin on QTc interval in the fed and fasted state in healthy Japanese and Caucasian subjects. Br J Clin Pharmacol. 2014 Jan;77(1):170-9. doi: 10.1111/bcp.12168.
Results publication: PubMed 22775199Taubel J, Lorch U, Ferber G, Singh J, Batchvarov VN, Savelieva I, Camm AJ. Insulin at normal physiological levels does not prolong QT(c) interval in thorough QT studies performed in healthy volunteers. Br J Clin Pharmacol. 2013 Feb;75(2):392-403. doi: 10.1111/j.1365-2125.2012.04376.x.
The FIRST to obtain MHRA Standard and Supplementary Accreditation for two hospital based clinical trial units.Link provided by the sponsor.

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.

Ulrike Lorch, MD FRCA FFPM principal investigator

Richmond Pharmacology Limited

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 11 inclusion and 34 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 20 Aug 2014. 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. 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?

Yes. Results are posted in the registry (first posted 20 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

The Effect of Food (Fasted and Fed State) on the Degree of QT Prolongation Caused by Moxifloxacin (time frame: 0 (pre-dose), 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4 and 6 hours post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01642485, which also lists 5 linked publications.

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 20 Aug 2014.