A Study to Assess the Absorption, Metabolism and Excretion of [14C]-ANG-3777

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2021-06-30

Brief Summary

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The purpose of this study is to assess the mass balance recovery and metabolic profiling and identification of 14C-ANG-3777 administered as a single IV dose.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Open-label, non-randomized study. Blinding is not required.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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carbon-14-[14C]-ANG-3777

Administered IV as a single dose over 30 minutes on the morning of Day 1 following an 8 hour overnight fast and remain in the clinical unit until up to 168 hours after dosing (to Day 8). If mass balance criteria have not been met on Day 8, the clinical unit residency may be extended up to an additional 96 hours (to Day 12).

Group Type EXPERIMENTAL

carbon-14-[14C]-ANG-3777

Intervention Type DRUG

Arms assigned to this intervention will receive 240 mg, IV and not more than 5.2 MBq, Fasted

Interventions

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carbon-14-[14C]-ANG-3777

Arms assigned to this intervention will receive 240 mg, IV and not more than 5.2 MBq, Fasted

Intervention Type DRUG

Other Intervention Names

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Hepatocyte growth factor mimetic

Eligibility Criteria

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Inclusion Criteria

1. Healthy males
2. Aged 30 to 65 years inclusive at the time of signing informed consent
3. Body mass index (BMI) of 18.0 to 32.0 kg/m2 and weighing 50 to 120 kg as measured at screening
4. Must be willing and able to communicate and participate in the whole study
5. Must have regular bowel movements (ie average stool production of ≥1 and ≤3 stools per day)
6. Must provide written informed consent
7. Must agree to adhere to the contraception requirements

Exclusion Criteria

1. Subjects who have received any IMP in a clinical research study within the 90 days prior to Day 1
2. Subjects who are, or are immediate family members of, a study site or sponsor employee
3. Evidence of current SARS-CoV-2 infection.
4. History of any drug or alcohol abuse in the past 2 years
5. Regular alcohol consumption \>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)
6. A confirmed positive alcohol breath test at screening or admission
7. Current smokers and those who have smoked within the last 12 months. A confirmed breath carbon monoxide reading of greater than 10 ppm at screening or admission
8. Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months

Minimum Eligible Age

30 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes