Malaria, FalciparumPhase 2NCT07545681
A Phase 2A Study of a Novel Antimalarial Pyrrolidinamide in Adult Patients With Uncomplicated P. Falciparum Malaria
A Phase 2 study testing GSK3772701 600 mg, GSK3772701 900 mg and GSK3772701 150 mg in people with Malaria, Falciparum, run by GlaxoSmithKline.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Malaria, Falciparum
- What is being tested?
- GSK3772701 600 mg, GSK3772701 900 mg and GSK3772701 150 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 28 Jul 2026to 29 Jul 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
- Use of other investigational drugs at the time of enrolment, or within 6 weeks, or 5 half-lives prior to enrolment into this study, whichever is longer; or longer if required by local regulations, and for any other limitation of participation in an investigational trial based on local regulations.
- History of hypersensitivity to the study drug or drug formulation and capsule (Hypromellose (hydroxypropyl methylcellulose)) constituents.
- History of drug or alcohol abuse within 3 months prior to dosing, or clinical evidence of such abuse.
- Participants who in the opinion of the Investigator are unsuitable for participation in the study or cannot be enrolled due to logistical reasons.
- ALT >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 <=1.5xULN.
- Current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to first dose of study intervention.
- Positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study intervention.
- Note: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis C RNA test is obtained.
- Positive hepatitis C RNA test result at screening or within 3 months prior to first dose of study intervention.
- Note: Test is optional and participants with negative Hepatitis C antibody test are not required to also undergo Hepatitis C RNA testing.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Novel Antimalarial Pyrrolidinamide at Different Doses and Dose Durations, in Adult Patients With Uncomplicated P. Falciparum Malaria
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
- Being tested
- GSK3772701 600 mg, GSK3772701 900 mg, GSK3772701 150 mg, GSK3772701 400 mg, GSK3772701 50 mg
- Keywords
- GSK3772701, Antimalarial drug, Plasmodium falciparum, Malaria
- Medical subject headings
- Malaria, Falciparum, Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK3772701 600 mgDrug
A 600 mg dose of GSK3772701 administered orally, as 4 capsules of 150 mg.
GSK3772701 900 mgDrug
A 900 mg dose of GSK3772701 administered orally, as 6 capsules of 150 mg.
GSK3772701 150 mgDrug
A daily 150 mg dose of GSK3772701 administered orally on Day 1 and Day 2, as 1 capsule.
GSK3772701 400 mgDrug
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.
GSK3772701 50 mgDrug
A daily 50 mg dose of GSK3772701 administered orally on Day 1, Day 2 and Day 3, as 1 capsule.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1_Single Dose | Experimental | Participants receive a single GSK3772701 600 mg dose on Day 1. Receives: Drug: GSK3772701 600 mg |
| Cohort 2_ Single Dose | Experimental | Participants receive a single GSK3772701 900 mg dose on Day 1. Receives: Drug: GSK3772701 900 mg |
| Cohort 3_ Repeat Dose | Experimental | Participants receive a daily 150 mg dose of GSK3772701 on Day 1 and Day 2. Receives: Drug: GSK3772701 150 mg |
| Cohort 4_ Repeat Dose | Experimental | Participants receive a daily 400 mg dose of GSK3772701 on Day 1 and Day 2. Receives: 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. Receives: Drug: GSK3772701 50 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: From Day 1 up to Day 40
Secondary outcomes (8)
Area under the concentration (AUC) - time curve (AUC[0-t]) of GSK3772701
AUC(0-t) is defined as the area under the concentration-time curve from time zero to the time of the last evaluable concentration.
Measured: From Day 1 to Day 7
AUC(0-t) extrapolated to infinity (AUC[0-inf]) of GSK3772701
AUC(0-inf) is defined as the area under the concentration-time curve extrapolated to infinity calculated as: . AUC(0-inf) = AUC(0-t) + C(t) / λz.
Measured: From Day 1 to Day 7
Maximum observed concentration (Cmax) of GSK3772701
Measured: From Day 1 to Day 7
Time to maximum observed drug concentration (Tmax) of GSK3772701
Tmax is defined as time to reach the Cmax.
Measured: From Day 1 to Day 7
Apparent terminal half-life (t1/2) of GSK3772701
Apparent terminal phase half-life in plasma (and blood), calculated as loge (2)/λz.
Measured: From Day 1 to Day 7
Trough concentration (Ctau) of GSK3772701 following multiple dose administration
Ctau is defined as the trough/pre-dose concentration after dosing interval, tau.
Measured: From Day 2 to Day 7
Observed accumulation ratio (R) of GSK3772701 for AUC [AUC(Ro)] following multiple dose administration
AUC-tau (Ro) is defined as the accumulation ratio for AUC(0-tau) comparing last day of dosing to Day 1.
Measured: From Day 2 or Day 3 to Day 7, compared to Day 1
Observed accumulation ratio of GSK3772701 based on Cmax (RCmax) following multiple doses
Cmax (RCmax) is defined as the accumulation ratio for Cmax comparing last day of dosing to Day 1.
Measured: From Day 2 or Day 3 to Day 7, compared to Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start28 Jul 2026 (estimated)
- Primary completion29 Jul 2027 (estimated)
- Study completion29 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malaria, FalciparumStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545681
- Sponsor's protocol ID
- 223257
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2026
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.