Tolerability and Potential ECG Effects After a Single Oral Dose of Pentoxyverine Citrate in Healthy Male and Female Volunteers

Study Overview
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Brief Summary
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The primary objective of this trial was to investigate the potential effects of pentoxyverine on the ECGs of healthy subjects. A secondary objective was the exploration of safety and tolerability. Pharmacokinetics (PK) were only to be investigated if necessary for the explanation of ECG effects.

Official Title
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A Phase I, Single-dose, Two-way Crossover Study to Investigate Tolerability and Potential ECG Effects After a Single Oral Dose of 192 mg Pentoxyverine Citrate (Corresponding to 121.5 mg Pentoxyverine Base) in Healthy Male and Female Volunteers (Randomised, Single-blind, Placebo-controlled)

Conditions
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Healthy

Intervention / Treatment
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* Drug: pentoxyverine citrate
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (blood pressure (BP), pulse rate (PR)) 12-lead ECG, clinical laboratory tests Age ≥21 and ≤45 years Body Mass Index (BMI) ≥18.5 and ≤29.9 kg/m² Signed and dated written informed consent prior to admission to the study in accordance with GCP and the local legislation. Exclusion Criteria: Any finding of the medical examination (including BP, PR, and ECG) deviating from normal and of clinical relevance Any evidence of a clinically relevant concomitant disease Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders Surgery of the gastrointestinal tract (except appendectomy) Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders History of relevant orthostatic hypotension, fainting spells or blackouts. Chronic or relevant acute infections History of relevant allergy/hypersensitivity (including allergy to drug or its excipients) Intake of drugs with a long half-life (> 24 hours) within at least one month or less than 10 half-lives of the respective drug prior to administration or during the trial Use of drugs which might reasonably influence the results of the trial or that prolong the QT/QTc interval based on the knowledge at the time of protocol preparation within 10 days prior to administration or during the trial Participation in another trial with an investigational drug within two months prior to administration or during the trial Smoker (> 10 cigarettes or > 3 cigars or > 3 pipes/day) Inability to refrain from smoking on trial days Alcohol abuse (more than 60 g/day) Drug abuse Blood donation (more than 100 mL within four weeks prior to administration or during the trial) Excessive physical activities (within one week prior to administration or during the trial) Any laboratory value outside the reference range that is of clinical relevance Inability to comply with dietary regimen of trial site A marked baseline prolongation of QT/QTc interval (e.g., repeated demonstration of a QTc interval >450 ms); A history of additional risk factors for torsade de pointes (e.g., heart failure, hypokalemia, family history of Long QT Syndrome)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pentoxyverine citrate vs. placebo<br>All subjects were allocated to receive both verum and placebo in randomised order | Drug: pentoxyverine citrate<br> <br> Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes from baseline in QTc interval |  | up to 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of adverse events |  | up to day 44 | 
| Blood pressure change from baseline |  | up to day 44 | 
| Pulse rate change from baseline |  | up to day 44 | 
| assessment of global tolerability by 4-point scale |  | up to day 44 |