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Not Yet Recruiting NCT07545681

A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria

Conditions: Malaria, Falciparum

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 70
Sponsor: GlaxoSmithKline

Summary

The study will evaluate the safety and efficacy of a new antimalarial drug GSK3772701 (a pyrrolidinamide), using different doses and treatment durations, in adult participants with uncomplicated Plasmodium (P.) falciparum malaria.

Eligibility Criteria

Inclusion Criteria: * Male and female patients aged 18 to 65 years. * Presence of malaria due to mono-infection with P. falciparum confirmed by: * Fever, as defined by axillary temperature \>=37.5°C or oral/tympanic temperature \>=38°C and, * Microscopically confirmed P. falciparum malaria parasite mono-infection, * A parasite count between 2,000 to 60,000 asexual parasite count/µL of blood for P. falciparum. * Have a BMI between \>=18 and \450 msec or QTcF \>480 msec for patients with bundle branch block. * Any clinically significant ECG abnormalities at Screening unrelated to malaria (including but not limited to, second degree AV block (Mobitz Type 2), complete heart block, ST changes, atrial fibrillation, atrial flutter, supraventricular tachycardia, ventricular tachycardia, prolonged QT interval. * History of malignancy (or current malignancy) of any organ system (other than localized carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases. * Creatinine \>=2 x ULN. * Significant illness within two weeks prior to screening. * Positive HIV antibody test at screening, or history of HIV infection based on past positive test result, clinical record or current treatment. * Severe vomiting, defined as more than 3 times in the 24 hours before screening or inability to tolerate oral treatment. * Severe diarrhoea defined as more than 3 watery stools per day in the 24 hours before screening. * Known history or evidence (based on clinical examination or investigation) of uncontrolled active cardiovascular disease (including hypertension), respiratory disease (including active tuberculosis even if treatment is ongoing), liver cirrhosis or liver disease (based on prior investigation, clinical signs and/or interpretation of liver enzymes), other active hepatic, renal, gastrointestinal, immunological, neurological, endocrine, infectious, or psychiatric disease. * Anaemia (Hb \2.0 x ULN. * Total bilirubin \>1.5 x ULN; Participants with Gilbert's syndrome can be included with total bilirubin \>1.5xULN as long as direct bilirubin is \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07545681). StuddyBuddy aggregates publicly available trial information.