Assess Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of Ruxolitinib With Artemether-lumefantrine
Source: ClinicalTrials.gov NCT04456634 ↗Summary
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participant With Treatment-Related Adverse Events as Assessed by CTCAE V4.03, All of Observed and Self-reported AEs Affected, by Treatment Regimen. |
6; 2 | — |
| PRIMARY Number of Participants With Changes of Systolic and Diastolic Blood Pressure |
2; 0 | — |
| PRIMARY Number of Participants With Changes in Heart Rate |
1; 0 | — |
| PRIMARY Number of Participants With ECG Changes |
2; 0 | — |
| SECONDARY AUECt of pSTAT3 Inhibition |
551; 186 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female (non-pregnant, non-lactating) aged 18 to 55 years inclusive.
- Contactable and available for the duration of the trial and for up to two weeks following the EOS visit.
- Total body weight greater than or equal to 50 kg, and a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive) at Screening and Day -1. BMI is an estimate of body weight adjusted for height. It is calculated by dividing the weight in kilograms by the square of the height in metres.
Health status
- Certified as healthy by a comprehensive clinical assessment (detailed medical history, full physical examination and special investigations).
- Vital signs measured after 5 min in the supine position:
- Systolic blood pressure (SBP) - 90-140 mmHg,
- Diastolic blood pressure (DBP) - 40-90 mmHg,
- Heart rate (HR) 40-100 bpm.
- ECG parameters for both males and females: QT ≤ 500 msec, QTcF ≤450 msec, QTcB ≤450 msec; PR interval ≤210 msec.
- Heterosexual female participants of childbearing potential who have, or may have, male sexual partners during the course of the study should be using an insertable (implant or IUD), injectable, transdermal or combination oral contraceptive approved by the TGA combined with a barrier contraceptive from the time of informed consent until EOS. Abstinent female participants must agree to start a double method if they start a sexual relationship with a male during the trial. Female participants must not be planning in vitro fertilisation within the required contraception period.
Women of non-childbearing potential who will not require contraception during the trial are defined as: surgically sterile (tubal ligation is not considered surgically sterile), post-menopausal (spontaneous amenorrhoea for ≥12 months, or spontaneous amenorrhoea for 6-12 months and follicle-stimulating hormone (FSH) ≥40 IU/mL; either should be together with the absence of oral contraceptive use for >12 months).
Male participants who have, or may have female sexual partners during the course of the study must agree to use a double method of contraception including condom plus diaphragm, or condom plus stable insertable (implant or IUD), injectable, transdermal or combination oral contraceptive by the female partner, from the time of informed consent through to EOS. Abstinent male participants must agree to start a double method if they begin a sexual relationship with a female during the trial, and through to EOS. Male participants with female partners that are surgically sterile or post-menopausal, or male participants who have undergone sterilisation and have had testing to confirm the success of the sterilisation, may also be included and will not be required to use above described methods of contraception.
Regulations
- Completion of the written informed consent process prior to undertaking any trial-related procedure.
- Must be willing and able to communicate and participate in the whole trial.
- Agree to adhere to Lifestyle Considerations (see Section 4.3.3) throughout trial duration and be willing to consume 250 mL full-fat milk with each dose of AL.
Exclusion Criteria
Medical history and clinical status
- Known hypersensitivity to ruxolitinib, artesunate or any of its excipients, artemether, lumefantrine or other artemisinin derivatives, proguanil/atovaquone, primaquine, or 4-aminoquinolines.
- Haematology, biochemistry or urinalysis results that are abnormal/outside of the laboratory normal reference ranges AND are either:
- Considered clinically signficant by the Principal Investigator or delegate; OR
- Considered not clinically significant by the Principal Investigator or delegate BUT ARE ALSO outside of Sponsor-approved clinically acceptable laboratory ranges in Appendix 1.
NOTE: Participants are not excluded if abnormal/out of laboratory normal reference range results are considered not clinically significant by the Principal Investigator or delegate AND are within the ranges sp
Data sourced from ClinicalTrials.gov (NCT04456634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.