Trials Sponsors Conditions Drugs Pricing

Conditions

Invasive fungal infections (IFIs)Healthy Adult Participants

Keywords

Drug-drug interaction studyPharmacokineticsHealthy adultsFosmanogepixManogepix

Outcome Measures

Primary Outcomes (4)

Part 1: Maximum Plasma Concentration (Cmax) of the medicine cocktail when administered alone or in combination with manogepix at steady state
The effect of fosmanogepix will be checked by comparing the blood levels of the medicine cocktail when taken alone or after administration of fosmanogepix.
At Day 1 and Day 22
Part 1: Area under the concentration-time curve (AUC) of the medicine cocktail when administered alone or in combination with manogepix at steady state
The effect of fosmanogepix will be checked by comparing the blood levels of the medicine cocktail when taken alone or after administration of fosmanogepix.
At Day 1 and Day 22
Part 2: Maximum Plasma Concentration (Cmax) of probe substrate cocktail when administered alone or in combination with manogepix at steady state
The effect of fosmanogepix will be checked by comparing the blood levels of probe substrate cocktail when taken alone or after administration of fosmanogepix.
From Day 1 to Day 20

Secondary Outcomes (2)

Part 1: Placebo-corrected change from baseline in the heart-rate corrected QT interval using Fridericia's formula
From Day 5 to Day 12
Number of participants reporting treatment emergent adverse events (TEAEs)
From screening to week 13.5

Study Arms (2)

Part 1

EXPERIMENTAL

Fosmanogepix or placebo + probe substrate cocktail Participants will receive study intervention as follows: * Day 1 and Day 22: probe substrate cocktail * Days 5 to 24: Placebo or fosmanogepix

Drug: FosmanogepixOther: PlaceboOther: The medicine cocktail (caffeine, bupropion, flurbiprofen, omeprazole, dextromethorphan and midazolam)

Part 2

EXPERIMENTAL

Fosmanogepix + Probe substrates Participants will receive study intervention as follows: * Day 1 and Day 19: Repaglinide * Day 2 and Day 20: Rosuvastatin and Digoxin * Days 6 to 21: Fosmanogepix

Drug: FosmanogepixOther: Probe substrates (repaglinide, rosuvastatin, and digoxin)

Interventions

FosmanogepixDrug

Fosmanogepix will be administered as an intravenous infusion or as an oral tablet

Part 1Part 2

PlaceboOther

Placebo will be administered as an intravenous infusion or as an oral tablet

Part 1

Eligibility Criteria

Age18 Years - 55 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64)

You may qualify if:

Body mass index of 18 to 30 kg/m2, inclusive, and a total body weight \> 50 kg at screening
Healthy, as determined by medical history, physical examination, and other procedures, including blood pressure and pulse rate, 12-lead ECG, clinical laboratory tests (hematology, clinical chemistry, coagulation, urinalysis), and an estimated glomerular filtration rate (eGFR) ≥ 80 mL/min/1.73m2 (CKD-EPI formula), at Screening and Day -2.

Sponsors & Collaborators

Basilea Pharmaceutica International AG Allschwil
Industrylead
Basilea Pharmaceutica
Industrylead
Biomedical Advanced Research and Development Authority

Study Sites (1)

ICON Early Clinical & Bioanalytical Solutions

Groningen, Netherlands, 9728 NZ, Netherlands

RECRUITING

MeSH Terms

Interventions

CaffeineBupropionFlurbiprofenOmeprazoleDextromethorphanMidazolamrepaglinideRosuvastatin CalciumDigoxin

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-Ring

Study Officials

Thomas Kaindl, MD
Basilea Pharmaceutica International Ltd, Allschwil
STUDY DIRECTOR

Central Study Contacts

Thomas Kaindl, MD

CONTACT

+41615671505 thomas.kaindl@basilea.com

Study Design

Study Type: interventional
Phase: phase 1
Allocation: NON RANDOMIZED
Masking: SINGLE
Who Masked: PARTICIPANT
Purpose: OTHER
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

October 12, 2026

First Posted

October 19, 2026

Study Start

October 1, 2026

Actual (reported)

Primary Completion

March 9, 2027

Estimated

Planned date reported by the registry; this milestone is not confirmed as achieved.

You may not qualify if:

Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
Active infection.
Any condition possibly affecting drug absorption.
History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, HBcAb, HCVAb, and syphilis
Subjects who are pregnant, breastfeeding, or plan to become pregnant during the study.
Medical history of neurological disorders, including abnormal movements or seizures.
Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, or laboratory abnormality that may increase the risk of study participation or, in the Investigator's judgment, make the subject inappropriate for the study.
History of allergy or hypersensitivity or other contraindication to any of the drugs to be administered, or to one of the components of the study drugs, as determined by the Investigator.
History of risk factors for QT prolongation, Torsades de Pointes, or uncorrected hypokalemia/hypomagnesemia.
Previous administration of an investigational drug (including a vaccine) within 60 days or five half-lives (whichever is longer) prior to the first study drug administration on Day 1.
For Part 1 only, poor metabolizers of CYP2D6 (\*4/\*4; \*4/\*5; \*5/\*5), CYP2C9 (\*2/\*2; \*2/\*3; \*3/\*3), and/or CYP2C19 (\*2/\*2) (determined at Screening or from available historical data).
Supine systolic blood pressure (SBP) \> 140 mmHg or diastolic blood pressure (DBP) \> 90 mmHg, and pulse rate \> 100 beats per minute (bpm) or \< 40 bpm Supine 12-lead ECG demonstrating any of the following clinically-relevant abnormalities that may affect subject safety or interpretation of the study results: QTcF interval \> 450 msec, QRS interval \> 120 msec, complete left bundle branch block, signs of an acute or indeterminate-age myocardial infarction, ST T interval changes suggestive of myocardial ischemia, second- or third-degree AV block, or serious bradyarrhythmias or tachyarrhythmias
Subjects with AST or ALT \> 1.0 × ULN.
Blood (excluding plasma) donation or blood loss \> 500 mL within 60 days prior to Screening.
History of alcohol abuse or binge drinking and/or any other illicit drug abuse or dependence.
+3 more criteria

A Multiple-dose Study Investigating the Drug-drug Interaction Potential and QTc Effects of Fosmanogepix in Healthy Adult Subjects

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (2)

Study Arms (2)

Part 1

Part 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (4)

Secondary Outcomes (2)

Study Arms (2)

Part 1

Part 2

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source records

Locations