A Study of Fosmanogepix in Healthy Adult Chinese Subjects
Phase 1
Recruiting
- Conditions
- Healthy
- Interventions
- Drug: Oral FosmanogepixDrug: IV FosmanogepixDrug: oral placeboDrug: IV placebo
- Registration Number
- NCT06961708
- Lead Sponsor
- Basilea Pharmaceutica
- Brief Summary
The purpose of this study is to investigate the pharmacokinetics and safety of the investigational drug fosmanogepix including its active moiety manogepix following a single dose and multiple doses (by intravenous infusion (IV) or orally) in healthy Chinese adults.
The study consists of 2 consecutive Parts (Part-1, single-dose part followed by Part-2, multiple-dose part) including a total of approximately 52 participants.
Part-1 duration will be up to 64 days including 4 visits at the clinical site and Part-2 duration will be up to 70 days including 5 visits at the clinical site. The study will include a total of 4 study sub-groups (Cohorts 1-4) in which fosmanogepix or placebo will be administered in different strengths orally or IV.
Participants will be enrolled and randomly assigned to study drug.
During the study, serial blood samples will be collected to understand how fosmanogepix is changed and eliminated from the body. Participants will also receive physical examination and other tests. This will help to understand if fosmanogepix is safe.
All data analyses will be descriptive (no statistical analysis will be provided).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- Body mass index (BMI) of 18.0 to 30.0 kg/m2 inclusive, and a total body weight > 45 kg for females and > 50 kg for males at Screening.
- Subjects who are overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, vital signs, creatinine, and estimated creatinine clearance (Cockcroft-Gault formula).
Exclusion Criteria
- Active acute or chronic infection, including, but not limited to upper airway infection, urinary tract infection, or skin infection at Screening.
- Any condition possibly affecting drug absorption.
- Medical history of neurological disorders including abnormal movements or seizures.
- Use of prescription or non-prescription drugs, including vaccines, and dietary and herbal supplements from Screening or within five half-lives (whichever is longer) prior to the first dose of study drug and throughout the study.
- Screening supine blood pressure (BP) ≥ 140 mmHg (systolic) or ≥ 90 mmHg (diastolic), and pulse rate (PR) > 100 beats per minute (bpm) or < 50 bpm, following at least 5 minutes of supine rest.
- Body temperature higher than 37.5 °C.
- Screening supine 12 lead ECG demonstrating clinically relevant abnormalities that may affect subject safety or interpretation of study results.
- Subjects with any of the following abnormalities in clinical laboratory tests at Screening, as assessed by the local laboratory and confirmed by a single repeat test, if deemed necessary:
- AST or ALT ≥ 1.0 × ULN.
- Total bilirubin ≥ 1.5 × ULN.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 (single dose) Oral Fosmanogepix Participants will receive fosmanogepix or placebo by oral administration Cohort 1 (single dose) oral placebo Participants will receive fosmanogepix or placebo by oral administration Cohort 2 (single dose) IV Fosmanogepix Participants will receive fosmanogepix or placebo by IV infusion Cohort 2 (single dose) IV placebo Participants will receive fosmanogepix or placebo by IV infusion Cohort 3 (multiple dose) IV placebo Participants will receive fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of fosmanogepix or placebo via IV infusion from Day 2 to Day 7 Cohort 3 (multiple dose) IV Fosmanogepix Participants will receive fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by a maintenance daily dose of fosmanogepix or placebo via IV infusion from Day 2 to Day 7 Cohort 4 (multiple dose) Oral Fosmanogepix The participants will receive fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7. Cohort 4 (multiple dose) IV Fosmanogepix The participants will receive fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7. Cohort 4 (multiple dose) IV placebo The participants will receive fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7. Cohort 4 (multiple dose) oral placebo The participants will receive fosmanogepix or placebo as an IV infusion twice 12 hours apart on Day 1 followed by an IV maintenance daily dose on Day 2 and Day 3, and then switched to oral administration (of fosmanogepix or placebo) daily from Day 4 to Day 7.
- Primary Outcome Measures
Name Time Method Maximum Observed Plasma Concentration (Cmax) of manogepix in Part-1 pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose Time to peak manogepix concentration (Tmax) of manogepix in Part-1 pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose Area under the plasma concentration vs. time curve for 0-24 hours (AUC24) of manogepix in Part-1 pre-dose, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose Time to peak manogepix concentration (Tmax) of manogepix in Part-2 pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7 Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of manogepix in Part-1 pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose Area Under the Curve From Time Zero to Extrapolated Infinite Time [AUC (0 - ∞)] of manogepix in Part-1 pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose Maximum Observed Plasma Concentration (Cmax) of manogepix in Part-2 pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7 Area under the concentration-time curve at steady state over the dosing interval tau (AUCtau) of manogepix in Part-2 pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240, 360 hours postdose on Day 7
- Secondary Outcome Measures
Name Time Method Number of participants reporting adverse events (AEs) in Part-1 Screening to follow-up (Day 29-36) Number of participants reporting adverse events (AEs) in Part-2 Screening to follow-up (Day 35-42) Plasma protein binding of manogepix: Fraction unbound (fu) in Part 1 pre-dose and 3 hours postdose
Trial Locations
- Locations (1)
Shanghai Xuhui Central Hospital, Longchuan North Road
🇨🇳Shanghai, China
Shanghai Xuhui Central Hospital, Longchuan North Road🇨🇳Shanghai, China