Phase 1 N=48 Cardiac Safety Evaluation of P03277
Healthy Volunteers
Primary: Change-from-baseline Mean Effect of P03277 on QT Interval Expressed as QTc According to Fridericia's Formula (∆QTcF) — 0.97; 5.05; 0.24; -0.11 milliseconds
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 1 N=47 This Study in Healthy Men and Women Tests Whether BI 409306 Has an Effect on the ECG (Thorough QT Study)
Healthy
Primary: Change From Baseline in QTcF at That Timepoint Between 20 Minutes to 24 Hours After Drug Administration Where the Difference of Means in QTcF Changes From Baseline…
Phase 1 N=48 Phase I Study of OPC-61815
Congestive Heart Failure
Primary: Time-matched Difference Between the OPC-61815/Moxifloxacin and Placebo Data in Change From Baseline for QTcF in 12-lead Holter Electrocardiogram (ECG) — 0.9; 0.0; 9.9…
Phase 1 N=46 A Study in Healthy People to Test Whether Different Doses of BI 1015550 Have Potential to Induce Heart Rhythm Abnormalities
Healthy
Primary: The Maximum Mean Difference Between Each Single Dose of Either a Low Dose or a High Dose of Nerandomilast and Placebo in QTcF Changes From Baseline Between 20 Min to 24…
Phase 1 N=44 A Study To Evaluate The Effect Of PF-04447943 On Qtc Interval In Healthy Adult Subjects
Healthy
Primary: Time-Matched Mean Difference in Corrected QT Interval Using Fridericia's Correction Method (QTcF) for PF-04447943 and Placebo at 0.5 Hour Post-Dose — 404.09; 408.92…
Phase 1 N=22 Study of the Electrocardiographic Effects of Ranolazine, Dofetilide, Verapamil, and Quinidine in Healthy Subjects
Drug-induced Surface ECG Changes
Primary: Placebo, and Baseline-adjusted Changes in PR, QRS, J-Tpeak, Tpeak-Tend and QTc — 6.5; 2.3; 32.1; 5.1 ms — p=<0.05
Phase 1 N=57 Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
Pediculosis
Primary: Difference Between Active and Placebo for Time Matched Baseline Adjusted Mean QTcF — -9.7; -9.2; 6.1 milliseconds
Phase 1 N=66 Phase 1 Study for IPG11406 in Health Volunteer
Inflammatory Bowel Diseases
Primary: Safety Indicators：Adverse Event — 1; 3; 2; 3 Participants
Phase 1 N=60 Effect of a Single Oral Dose of Moxidectin on the Cardiac QT Interval of Healthy Volunteers
QT Effects in Healthy Volunteers
Primary: Mean Change From Baseline in QTc Interval (Corrected by Friderica's Formula, dQTcF) Associated With Plasma Moxidectin Concentrations After a Single Dose — -5.1; -4.5…
Phase 1 N=32 A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval
Dyslipidemias
Primary: Change From Baseline in Fridericia's Correction for QT Interval (QTcF) — -4.6; 11.5; -6.0; -6.1 msec
Phase 1 N=60 CiPA Phase 1 ECG Biomarker Validation Study
Drug-induced QT Prolongation · Pharmacokinetics · Pharmacodynamics
Primary: Change From Baseline J-Tpeakc With "Balanced Ion Channel" Drugs (Ranolazine, Verapamil, Lopinavir / Ritonavir) — -8.3; -7.8; -11.5; -10.9 ms
Phase 1 N=112 A Study to Investigate the Effects of CBP-307 on the Heart Rate-corrected QT Interval (QTc) in Healthy Subjects
Autoimmune Diseases
Primary: Change-from-baseline QT Interval Corrected for Heart Rate Using Fridericia's Method (QTcF) — 1.5; 0.9 msec
Phase 1 N=27 A Study to Evaluate the Effect of MCI-186 at Therapeutic and Supra-Therapeutic Doses on the QT Interval(QT)/Corrected QT Interval(QTc) Interval in Healthy Subjects
Healthy Adult Subjects
Primary: Change From Baseline in QTcF(ΔQTcF) With Placebo Adjustment (ΔΔQTcF) at Cmax of MCI-186 — -0.5; 0.5 ms
Phase 1 N=62 Phase 1 Study of ELX-02 in Healthy Adult Subjects
Genetic Disease · Nonsense Mutation
Primary: Pharmacokinetic Parameters - Plasma AUC0-24 — 1105.126; 3125.484; 11018.22; 28235.823 ng*h/mL
Phase 1 N=24 A Study to Assess the Effect of Verinurad on the Electric Activity of the Heart
Healthy Volunteers (Intended Indication: Chronic Kidney Disease)
Primary: Model Predicted Baseline-corrected and Placebo-corrected QT Interval Corrected for Heart Rate (HR) Using Fridericia's Formula (QTcF)(ΔΔQTcF) (Derived From…
Phase 1 N=62 A Study of LY3009104 in Healthy Participants
Healthy Participants
Primary: Change From Baseline Through 24 Hours Postdose in Population-Corrected QT (QTcP) Interval — -2.5; -2.4; 9.7; -1.7 milliseconds (msec)
Phase 1 N=70 Study to Assess the Effect of Omecamtiv Mecarbil (OM) on QT/QTc Intervals in Healthy Adults
QT Intervals Changes · QTc Intervals Changes
Primary: Placebo-corrected Change From Baseline in QT Interval Corrected for Heart Rate Based on the Fridericia Method (QTcF) After Omecamtiv Mecarbil Dosing in Part B — -2.6…
Phase 1 N=33 Study Evaluating ECG Effects, Safety, Tolerability and Pharmacokinetics of Single Doses of Modufolin (Arfolitixorin) in Healthy Volunteers Tetrahydrofolate in Healthy Male Volunteers
Phase I Study in Healthy Volunteers to Evaluate ECG Effect
Primary: Change-from-baseline QTcF (ΔQTcF) — 2.8; 9.2; 8.5; 1.1 msec
Phase 1 N=48 Thorough QT Study to Evaluate the Effects of BI 207127 (Deleobuvir) Combined With Faldaprevir on Cardiac Safety Parameters in Healthy Subjects.
Healthy
Primary: Maximum Mean Placebo-corrected QTcN Change From Baseline Between 1 to 24 Hours on Day 1 for the Combination Therapy — -0.47; -8.37 ms
Phase 1 N=56 Dose-finding Pharmacokinetic Study in Healthy Males
Healthy Volunteers
Primary: Levodopa Area Under the Concentration-time Curve From Time 0 to the 24 h PK Sample (AUC0-24) Time 0 to the 24 h PK Sample (AUC0-24) — 4300; 5423; 7439; 9046 h*ng/ml
Phase 4 N=50 Evaluation of Whether Deferiprone Affects QT Interval in Healthy Subjects
Prolonged QTc Interval
Primary: Maximum Difference in Change From Baseline in ddQTcF Following a Single Dose of 33 mg/kg Deferiprone — 1.4; -1.6 milliseconds
Phase 1 N=40 Thorough QT Study of Intravenous Amisulpride
Healthy
Primary: Maximal Mean ΔΔQTcF — 5.0; 23.4; 0.8; 12.3 milliseconds
Phase 1 N=48 Effects of HSK3486 on Cardiac Repolarization in Health Subjects (TQT)
Anesthesia; Adverse Effect · Cardiac Arrhythmia
Primary: Change-from-baseline in QTc Interval — 2.1; 5.1; -0.1; 4.1 ms — p=<0.05
Phase 1 N=67 Trial to Evaluate the Effect of Eslicarbazepine Acetate on Cardiac Repolarization
Epilepsy
Primary: QTcI - QT Interval Individually Corrected for Heart Rate - Day 5 — -8.05; -6.15; -2.77; -4.39 msec
Phase 1 N=60 Effect of Anagrelide Hydrochloride on Any Changes in Heart Function in Healthy Volunteers
Healthy
Primary: Mean Difference Changes From Baseline Versus Placebo in QTcNi Intervals From Time-Matched Analysis by Largest Time Point — 7.0; 13.0; 12.6 msec — p=<0.001
Phase 2 N=136 A Study to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial
Spasticity
Primary: The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (ΔΔQTc) on Day 14. — -4.3; -0.5; -3.7; -2.0 milliseconds (msec)
Phase 1 N=54 To Assess the Effects of Single Oral Dose of Selumetinib [AZD6244; ARRY-142886] [Hyd-Sulfate]), on QTc Interval in Healthy Male Volunteers
Solid Tumours
Primary: Change From Baseline in QTcF — 2.0; -4.1; -4.2 msec
Phase 1 N=20 BI 409306 Cardiac Safety Trial in Healthy Volunteers
Healthy
Primary: Slope of the Placebo-corrected Change From Baseline of Heart Rate at Rest and Plasma Concentration Between 0 to 10 Hours — 0.80; 5.46 beats/min
Phase 1 N=23 A Study to Assess the Pharmacodynamic Effect of Single Doses of AZD9977 in Healthy Male Subjects
Pharmacodynamics · Healthy Subjects
Primary: Pharmacodynamics of AZD9977 Assessed Per Sodium/Potassium Ratio in Urine in Eplerenone Treatment Versus a Combination Treatment of Eplerenone and AZD9977. — -0.545…
Phase 1 N=30 Assessment of the Effect of Empagliflozin (BI 10773) as Single Dose on the QT Interval in Healthy Female and Male Subjects
Healthy
Primary: Empa 25mg: Mean QTcN Change From Baseline Between 1 and 4 Hours After Dosing — 3.68; 4.27 ms