Pharmacokinetic Interactions between Ciprofloxacin and Chloroquine / Proguanil Prophylaxis

Phase 1

• Conditions: Chloroquine/proguanil is used for malaria chemoprophylaxis in areas where chloroquine-resistant Plasmodium falciparum malaria is prevalent, except in regions of Africa where chloroquine/proguanil is no longer effective. Ciprofloxacin is a fluoroquinolone antibiotic used to treat a wide variety of infections, such as traveller`s diarrhoea. Only healthy subjects will be treated in this study.

• Registration Number: EUCTR2005-004905-27-GB
• Lead Sponsor: Dstl

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02-26
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 16

Inclusion Criteria

To participate in this study, subjects must meet the following criteria:

1. Ability and willingness to give written informed consent prior to study participation
2. Healthy male subjects aged between 18 and 50 years (inclusive)
3. Body Mass Index (BMI) within the range of > 21 and < 30 kg/m2
4. Vital signs within the following ranges:
• Pulse rate 40-90 bpm
• Systolic blood pressure 90-140 mmHg
• Diastolic blood pressure 50-90 mmHg
5. Ability to communicate well with the Investigator and to comply with the requirements of the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects meeting any of the following criteria will be excluded from participation in the study:

1. Presence of any clinically significant medical condition as determined by the Medical Advisor
2. Any clinically significant haematological or biochemical abnormality as determined by the Medical Advisor
3. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug (e.g. renal or liver disease, respiratory, immunological, endocrine or neurological disorders)
4. Any ECG abnormality other than sinus bradycardia or respiratory sinus arrhythmia
5. Known or suspected hypersensitivity or idiosyncratic reaction related to any of the investigational medicinal products
6. Positive test for hepatitis B surface antigen
7. History or evidence of alcohol abuse defined as an intake of more than 28 units per week (4 units per day), where 1 unit corresponds to 250 ml beer, 20 ml spirits/liqueur or one glass (100 ml) of wine
8. Participation in another clinical study within the three months prior to screening
9. Use of any prescription medication within the 14 days prior to screening
10. Use of any non-prescription medication within the last 7 days (apart from paracetamol), which may, in the opinion of the Medical Advisor, impact the safety aspects and/or objectives of the study
11. Donation of blood or blood products within the 3 months prior to screening, or the intention to donate blood or blood products within 3 months after completion of the study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified