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Fungal InfectionPhase 1NCT04804059

A Study to Assess the Mass Balance Recovery and Metabolite Profile & Identification of [14C]-APX001 in Healthy Males

A Phase 1 study testing [14C]-APX001 Oral Solution and [14C]-APX001 Solution for Infusion in people with Fungal Infection, run by Basilea Pharmaceutica at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a single-center, open-label, non-randomized, single dose study in healthy male subjects. It was planned to enroll 2 cohorts of 5 subjects (10 subjects in total), with the target of achieving data in 4 evaluable subjects per cohort. Read more about this study

Who is it for?
Ages 30 to 65 years, men onlyHealthy volunteers can take part
Conditions the study is for
Fungal Infection
What is being tested?
[14C]-APX001 Oral Solution and [14C]-APX001 Solution for Infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteUnited Kingdom
Study dates
17 Aug 2018to 26 Sep 2018
Phase
Phase 1
Are there results?
None posted in the registry

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 30 to 65 years
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Healthy males
  • Aged 30 to 65 years of age
  • Body mass index (BMI) of 18.0 to 32.0 kg/m2 or, if outside the range, considered not clinically significant by the investigator
  • Good state of health (mentally and physically) as indicated by a comprehensive clinical assessment (detailed medical history and a complete physical examination)
  • Must have been willing and able to communicate and participate in the whole study
  • Must have had regular bowel movements (i.e. average stool production of ≥1 and
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  • ≤3 stools per day)
  • Must have provided written informed consent
  • Must have adhered to the contraception requirements defined in Section 9.4 of the protocol (Appendix 16.1.1)

Who cannot join

  • Subjects who had received any IMP in a clinical research study within the previous 3 months or a similar 14C radioactive clinical trial within the previous 12 months
  • Subjects who were study site employees, or immediate family members of a study site or sponsor employee
  • Subjects who had previously been enrolled in this study.
  • History of any drug or alcohol abuse in the past 2 years
  • Regular alcohol consumption in males >21 units per week (1 unit = ½ pint beer, or a 25 mL shot of 40% spirit, 1.5 to 2 units = 125 mL glass of wine, depending on type)
  • Current smokers and those who had smoked within the last 12 months. A breath carbon monoxide (CO) reading of greater than 10 ppm at screening and admission
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  • Current users of e-cigarettes and nicotine replacement products and those who had used these products within the last 12 months
  • Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeded 5 millisieverts (mSv) in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, was to participate in the study
  • Subjects who did not have suitable veins for multiple venipunctures/cannulation as assessed by the investigator at screening
  • Clinically significant abnormality on electrocardiogram (ECG) as judged by the investigator
  • Clinically significant abnormal biochemistry, hematology or urinalysis at screening as judged by the investigator (laboratory parameters are listed in Appendix 1 of the protocol, Appendix 16.1.1)
  • Positive drugs of abuse test result (drugs of abuse tests are listed in Appendix 1 of the protocol, Appendix 16.1.1)
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
  • Evidence of renal impairment at screening, as indicated by an estimated creatinine clearance of <80 mL/min using the Cockcroft-Gault equation
  • History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal (GI) disease, neurological or psychiatric disorder, as judged by the investigator
  • Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever was allowed unless it was active
  • Donation or loss of greater than 400 mL of blood within the previous 3 months
  • Subjects who were taking, or had taken, any prescribed or over-the-counter drug (other than 4 g per day paracetamol) or herbal remedies in the 14 days before IMP administration (see Section 11.4 of the protocol, Appendix 16.1.1). Exceptions may have applied on a case by case basis, if considered not to interfere with the objectives of the study, as agreed by the PI and sponsor's medical monitor.
  • Failure to satisfy the investigator of fitness to participate for any other reason

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Quotient Sciences

    Ruddington, Nottingham, NG11 6JS

Other trials in United Kingdom

About this study

Official title: An Open Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-APX001 in Healthy Male Subjects After Oral and Intravenous Dosing

This is a single-center, open-label, non-randomized, single dose study in healthy male subjects. It was planned to enroll 2 cohorts of 5 subjects (10 subjects in total), with the target of achieving data in 4 evaluable subjects per cohort. Five subjects were to receive a single oral dose of APX001 and not more than (NMT) 3.1 megabecquerel (MBq) (84.0 microcurie [μCi]) 14C in the fed state. Five subjects were to receive a single IV administration containing APX001 and NMT 3.4 MBq (93.0 μCi) 14C in the fed state.

Being tested
[14C]-APX001 Oral Solution, [14C]-APX001 Solution for Infusion
Medical subject headings
Mycoses

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-APX001 Oral SolutionDrug

    Total dose containing NMT 3.1 MBq (84.0 µCi) 14C

  • [14C]-APX001 Solution for InfusionDrug

    Total dose containing NMT 3.4 MBq (93.0 µCi) 14C

Study groups in NCT04804059
Study groupRoleWhat they receive
Cohort AExperimental[14C]-APX001 Oral Solution
Receives: Drug: [14C]-APX001 Oral Solution
Cohort BExperimental[14C]-APX001 Solution for Infusion
Receives: Drug: [14C]-APX001 Solution for Infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mass balance recovery as measured by mass unit equiv/g after a single oral or single intravenous (IV) dose of carbon-14 (14C)-labelled APX001 ([14C]-APX001).

    Measured: 3 weeks

  2. Profiling of metabolites of [14C]-APX001 in plasma and excreta.

    Plasma, urine and feces samples from subjects dosed with [14C]-APX001 were analyzed using high resolution, accurate mass liquid chromatography tandem mass spectrometry (LC-MS/MS) with in-line fraction collection and off-line counting to obtain [14C]-radiochromatographic profiles and provide information on the nature of the radioactive components present, including chemical structure identification.

    Measured: 3 weeks

Secondary outcomes (2)

  1. Elimination pathway of [14C]-APX001 following a single oral or single IV dose of [14C]-APX001.

    Amount of radioactivity recovered from urine and feces over time was measured by liquid scintillation counting (LSC) and expressed as a percentage of administered radioactivity.

    Measured: 3 weeks

  2. Extent of distribution of total radioactivity into blood cells following a single oral or single IV dose of [14C]-APX001.

    Amount of radioactivity in whole blood over time was quantified by LSC and expressed in ng equivalents free drug/g.

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start17 Aug 2018
  3. Primary completion26 Sep 2018
  4. Study completion26 Sep 2018

Resources

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 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04804059
Sponsor's protocol ID
APX001-104
Other IDs
C4791004
Status last verified
May 2024
First submitted
1 Oct 2020
Last updated
17 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Hodges MR, Ople E, Evans P, Pantophlet AJ(, Richardson J, Williams D, Tripathy S, Tawadrous M, Jakate A. A phase 1 open label study to assess the human mass balance and metabolite profile of 14C-fosmanogepix, a novel Gwt-1 inhibitor in healthy male participants. Antimicrob Agents Chemother. 2024 Aug 7;68(8):e0027324. doi: 10.1128/aac.00273-24. Epub 2024 Jul 16.

    PubMed 39012090

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-APX001 Oral Solution and [14C]-APX001 Solution for Infusion in people with Fungal Infection, run by Basilea Pharmaceutica at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mass balance recovery as measured by mass unit equiv/g after a single oral or single intravenous (IV) dose of carbon-14 (14C)-labelled APX001 ([14C]-APX001). (time frame: 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04804059, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2024.

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