BOHEMIA Pk400

Phase 2

• Conditions: Malaria; PK/PD of ivermectin in relation to malaria vector control

• Registration Number: PACTR202001893991170
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-13
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

i.Male or female 18 - 45 years old;
ii.Body weight over 50Kg;
iii.Good health or no medical conditions that could interfere with the study according to the opinion of the study clinician;
iv.Willingness to participate voluntarily in all study procedures;
v.Plans to remain available for study participation within the next 7 months;
vi.Use of effective method of contraception documented through a family planning card for the duration of study for female participants;
vii. Ability to give informed consent and communicate with the study personnel.

Exclusion Criteria

i.Feeling sick or presenting signs of sickness, which are considered by the project physician to not be temporary condition or likely to resolve before pre-enrolment screening;
ii.Body weight below 50Kg;
iii.Positive for malaria rapid diagnostic test (mRDT);
iv.Lactating or pregnant verified through ß-hCG urine test;
v.Clinically significant laboratory abnormality as judged by the study clinician;
vi.Receiving or having received in the past 30 days treatments that could, in the eyes of the investigator, interfere with the study;
vii.Hypersensitivity against any of the study drugs.

Study & Design

• Study Type: Interventional
• Study Design: Not specified