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

NCT02183649 | Completed Phase 1

• 1 other identifier: 1265.1
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• changes from baseline in QTc interval

  up to 24 hours

Secondary Outcomes (4)

• 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

Study Arms (1)

pentoxyverine citrate vs. placebo

EXPERIMENTAL

All subjects were allocated to receive both verum and placebo in randomised order

Drug: pentoxyverine citrate; Drug: Placebo

Interventions

pentoxyverine citrate DRUG

pentoxyverine citrate vs. placebo

Placebo DRUG

pentoxyverine citrate vs. placebo

Eligibility Criteria

• Age: 21 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Interventions

carbetapentane

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2014
• First Posted: July 8, 2014
• Study Start: November 1, 2009
• Primary Completion: December 1, 2009
• Last Updated: July 8, 2014

Record last verified: 2014-07