Back to results

Radiolabelled IV and Oral Metabolism Study of F901318 (ADME)

Primary Purpose

Invasive Aspergillosis

Status

Withdrawn

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

IV F901318

Oral F901318

About this trial

This is an interventional other trial for Invasive Aspergillosis

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Healthy males who do not wish to father children within the 6 months following IMP administration.
Age 40 to 65 years of age at the time of signing the ICF.
Body mass index of 18.0 to 35.0 kg/m2, with a weight of 50 to 100 kg.
Must be willing and able to communicate and participate in the whole study.
Subjects must be in good health as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations.
Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day).
Must provide written informed consent and agree to abide by the study restrictions
Must agree to use an adequate method of contraception during the study and for 6 months after study discharge

Exclusion Criteria:

Subjects who have received any IMP in a clinical research study within the previous 3 months prior to dosing.
Subjects who are study site employees, or immediate family members of a study site or sponsor employee.
Subjects who have previously been enrolled in this study or have previously been exposed to F901318.
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, 25 mL of 40% spirit or a 125 mL glass of wine).
Current smokers and those who have smoked or used nicotine containing products (eg electronic cigarettes) within the last 6 months. A confirmed positive urine cotinine test at screening or admission.
Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 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 1999, shall participate in the study.
Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening.

Sites / Locations

Quotient Clinical

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intravenous

Oral

Arm Description

Intravenous AUC0-infinity

Oral AUC0-infinity

Outcomes

Primary Outcome Measures

Mass balance

Metabolic profiling over 28 days

Secondary Outcome Measures

Full Information

NCT ID

NCT02912026

First Posted

September 21, 2016

Last Updated

July 24, 2019

Sponsor

F2G Biotech GmbH

Collaborators

Quotient Clinical

1. Study Identification

Unique Protocol Identification Number

NCT02912026

Brief Title

Radiolabelled IV and Oral Metabolism Study of F901318

Acronym

ADME

Official Title

An Open-Label, Single-Dose, Single-Period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-F901318 Administered Via the Intravenous and Oral Routes to Healthy Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

July 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Major change to study design

Study Start Date

May 2019 (Anticipated)

Primary Completion Date

July 2019 (Anticipated)

Study Completion Date

July 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

F2G Biotech GmbH

Collaborators

Quotient Clinical

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

Open label radiolabelled metabolism study of intravenous and oral solution forms of F901318. Five healthy male subjects will receive IV and five will receive an oral solution. Blood, urine and faeces will be collected over a period adequate to obtain 90% recovery of parent compound and to determine the metabolic profile of both IV and oral forms.

Detailed Description

Subjects will be screened for eligibility to participate in the study up to 28 days before dosing. Eligible subjects will be admitted to the clinical unit on the evening of Day -1 prior to investigational medicinal product (IMP) administration, and will be dosed on the morning of Day 1. In Cohort 1 (Regimen A), subjects will be dosed after a light breakfast; to assess tolerability of the IV administration, the first subject will be dosed at least 30 min prior to dosing the second subject. All subsequent dosing of the IV formulation will be staggered by at least 15 min. In Cohort 2 (Regimen B), subjects will be dosed following an overnight fast with an appropriate interval between subjects based on logistical requirements. Subjects will remain resident in the clinic up to 336 h post-dose (Day 15). It is planned that subjects will return to the clinical unit for 2 further 24 h residency periods on Day 21 and Day 28 if discharge criteria outlined in this protocol are not met. It is planned that subjects will be released from the study as a group when all subjects have achieved a mass balance cumulative recovery of >90% or <1% of the dose administered has been collected in urine and faeces within 2 separate, consecutive 24 h periods. If this occurs earlier than Day 28, collection of all samples (blood, urine and faeces) will be stopped and the subjects will undergo discharge assessments. If this criterion has not been met by all subjects following the Day 28 return visit, home collections of urine and faeces may be requested at the discretion of the investigator for individual subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Invasive Aspergillosis

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intravenous

Arm Type

Experimental

Arm Description

Intravenous AUC0-infinity

Arm Title

Oral

Arm Type

Experimental

Arm Description

Oral AUC0-infinity

Intervention Type

Drug

Intervention Name(s)

IV F901318

Intervention Description

Metabolic profile AUC 0 to infinity

Intervention Type

Drug

Intervention Name(s)

Oral F901318

Intervention Description

Metabolic profile AUC 0 to infinity

Primary Outcome Measure Information:

Title

Mass balance

Description

Metabolic profiling over 28 days

Time Frame

28 days

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy males who do not wish to father children within the 6 months following IMP administration. Age 40 to 65 years of age at the time of signing the ICF. Body mass index of 18.0 to 35.0 kg/m2, with a weight of 50 to 100 kg. Must be willing and able to communicate and participate in the whole study. Subjects must be in good health as determined by a medical history, physical examination, 12-lead ECG and clinical laboratory evaluations. Must have regular bowel movements (ie, average stool production of ≥1 and ≤3 stools per day). Must provide written informed consent and agree to abide by the study restrictions Must agree to use an adequate method of contraception during the study and for 6 months after study discharge Exclusion Criteria: Subjects who have received any IMP in a clinical research study within the previous 3 months prior to dosing. Subjects who are study site employees, or immediate family members of a study site or sponsor employee. Subjects who have previously been enrolled in this study or have previously been exposed to F901318. 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, 25 mL of 40% spirit or a 125 mL glass of wine). Current smokers and those who have smoked or used nicotine containing products (eg electronic cigarettes) within the last 6 months. A confirmed positive urine cotinine test at screening or admission. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 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 1999, shall participate in the study. Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening.

Facility Information:

Facility Name

Quotient Clinical

City

Nottingham

State/Province

Nottinghamshire

ZIP/Postal Code

NG11 6JS

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Radiolabelled IV and Oral Metabolism Study of F901318

We'll reach out to this number within 24 hrs