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

NCT07545681 | Not Yet Recruiting Phase 2

• 1 other identifier: 223257
• Study Type: interventional
• Target: 70
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Malaria, Falciparum

Keywords

GSK3772701; Antimalarial drug; Plasmodium falciparum; Malaria

Outcome Measures

Primary Outcomes (2)

• Number of participants with serious adverse events (SAEs) overall, treatment related, and by severity

  A SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant; abnormal pregnancy outcomes; or any other situation according to medical or scientific judgment. The intensity of SAEs is assessed as per the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicates greater severity. Any = occurrence of the event regardless of intensity grade and treatment relationship. Treatment related = occurrence of the event which, in the investigator's opinion, is related to the administered treatment regardless of the intensity grade.

  From the date of informed consent signing (up to 24 hours prior to Day 1) up to Day 40 (end of the follow-up period)

• Number of participants with non-serious AEs overall, treatment related, and by severity

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. The intensity of non-serious AEs is assessed using the DAIDS criteria Version 2.1 where grades are defined based on numeric criteria as follows Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicates greater severity. Any = occurrence of the event regardless of intensity grade and treatment relationship. Treatment related = occurrence of the event which, in the investigator's opinion, is related to the administered treatment regardless of the intensity grade.

  From Day 1 up to Day 40

Secondary Outcomes (8)

• Area under the concentration (AUC) - time curve (AUC[0-t]) of GSK3772701

  From Day 1 to Day 7

• AUC(0-t) extrapolated to infinity (AUC[0-inf]) of GSK3772701

  From Day 1 to Day 7

• Maximum observed concentration (Cmax) of GSK3772701

  From Day 1 to Day 7

• Time to maximum observed drug concentration (Tmax) of GSK3772701

  From Day 1 to Day 7

• Apparent terminal half-life (t1/2) of GSK3772701

  From Day 1 to Day 7

Study Arms (5)

Cohort 1_Single Dose

EXPERIMENTAL

Participants receive a single GSK3772701 600 mg dose on Day 1.

Drug: GSK3772701 600 mg

Cohort 2_ Single Dose

EXPERIMENTAL

Participants receive a single GSK3772701 900 mg dose on Day 1.

Drug: GSK3772701 900 mg

Cohort 3_ Repeat Dose

EXPERIMENTAL

Participants receive a daily 150 mg dose of GSK3772701 on Day 1 and Day 2.

Drug: GSK3772701 150 mg

Cohort 4_ Repeat Dose

EXPERIMENTAL

Participants receive a daily 400 mg dose of GSK3772701 on Day 1 and Day 2.

Drug: GSK3772701 400 mg

Cohort 5_ Repeat Dose

EXPERIMENTAL

Participants receive a daily 50 mg dose of GSK3772701 on Day 1, Day 2 and Day 3.

Drug: GSK3772701 50 mg

Interventions

GSK3772701 600 mg DRUG

A 600 mg dose of GSK3772701 administered orally, as 4 capsules of 150 mg.

Cohort 1_Single Dose

GSK3772701 900 mg DRUG

A 900 mg dose of GSK3772701 administered orally, as 6 capsules of 150 mg.

Cohort 2_ Single Dose

GSK3772701 150 mg DRUG

A daily 150 mg dose of GSK3772701 administered orally on Day 1 and Day 2, as 1 capsule.

Cohort 3_ Repeat Dose

GSK3772701 400 mg DRUG

A daily 400 mg dose of GSK3772701 administered orally on Day 1 and Day 2, as 2 capsules of 150 mg and 1 capsule of 100 mg.

Cohort 4_ Repeat Dose

GSK3772701 50 mg DRUG

A daily 50 mg dose of GSK3772701 administered orally on Day 1, Day 2 and Day 3, as 1 capsule.

Cohort 5_ Repeat Dose

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<=30 kg/m2.
• Able to swallow oral medication.
• Signed informed consent, acknowledging understanding and willingness to comply with the requirements of the study. If the patient is unable to write, thumb print consent, signed by an impartial witness is permitted according to local ethical considerations.
• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
• A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
• Is a woman of non-childbearing potential (WONCBP) or
• Is a woman of childbearing potential (WOCBP) and using an acceptable contraceptive method, from Study Day 1, and during the study intervention period (40 +/-3 days).

You may not qualify if:

• Patients with signs and symptoms of severe/complicated malaria according to the WHO 2024 Criteria.
• Mixed Plasmodium infection, i.e., infection with more than one malaria (plasmodium) species (by microscopy; participant to be withdrawn from study treatment if PCR subsequently indicates presence of mixed infection).
• Abnormal values: QTcF \>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 \<=8.0g/dl) or known clinically important chronic underlying haematological disease such as sickle cell disease at screening.
• Significant chronic medical conditions which in the opinion of the investigator preclude enrolment into the study.
• Have received any antimalarial treatment in the preceding 6 weeks (see Section 6.10), as determined by history or medical record.
• Prior enrolment in this study and receipt of treatment with GSK3772701.

Sponsors & Collaborators

• GlaxoSmithKline: lead

MeSH Terms

Conditions

Malaria, Falciparum; Malaria

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases

Central Study Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718; GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466; GSKClinicalSupportHD@gsk.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open-label
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2026
• First Posted: April 22, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): July 22, 2027
• Study Completion (Estimated): July 22, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.