A Study of Fosmanogepix in Healthy Adult Chinese Subjects

Basilea Pharmaceutica54 enrolled

Overview

The purpose of this study was 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 consisted of 2 consecutive Parts (Part-1, single-dose part followed by Part-2, multiple-dose part) including a total of 54 subjects (32 subjects in Part-1 and 22 subjects in PART-2) randomized.

Part-1 duration including screening period was up to 64 days including 4 visits at the clinical site and Part-2 duration including screening period was up to 70 days including 5 visits at the clinical site. The study included a total of 4 study sub-groups (Cohorts 1-4) in which fosmanogepix or placebo was administered in different strengths orally or IV. Subjects were enrolled and randomly assigned to study drug. During the study, serial blood samples were collected to understand how fosmanogepix was changed and eliminated from the body. The primary objective of PART-1 (Single-dose) was to evaluate the pharmacokinetic (PK) profile of manogepix (active moiety of fosmanogepix) after single dose administration in healthy adult Chinese subjects. The primary objective of PART-2 (Multiple-dose) was to evaluate the PK profile of manogepix (active moiety of fosmanogepix) after repeated doses in healthy adult Chinese subjects. All data analyses are descriptive (no statistical analysis is provided).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Healthy

Interventions

Oral FosmanogepixDRUG

Oral Tablet

IV FosmanogepixDRUG

IV infusion

IV placeboDRUG

Matching IV placebo

oral placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Main criteria for inclusion and exclusion: * 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 were overtly healthy as determined by medical evaluation, including medical history, physical examination, laboratory tests, vital signs, creatinine, and estimated creatinine clearance (Cockcroft-Gault formula). Main 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.

Locations (1)

Shanghai Xuhui Central Hospital, Longchuan North Road

Shanghai, China

Outcomes

Primary Outcomes

Maximum Observed Plasma Concentration (Cmax) of Manogepix in Part-1

Pharmacokinetic (PK) parameter Cmax for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects

Time frame: 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

PK parameter Tmax for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects

Time frame: 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

PK parameter AUC 24 for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects

Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24 hours postdose

Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast) of Manogepix in Part-1

PK parameter AUClast for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects

Time frame: 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

PK parameter AUC (0 - ∞) for manogepix after a single oral administration of 400 mg or 800 mg fosmanogepix or after a single IV infusion of 600 mg or 1,000 mg fosmanogepix over 3 hours to healthy Chinese subjects

Time frame: pre-dose, 1, 2, 3, 4, 6, 8, 12, 24, 36, 48, 72, 96, 144, 240 hours postdose

Data from ClinicalTrials.gov

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A Study of Fosmanogepix in Healthy Adult Chinese Subjects

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes