A PHASE 1, OPEN-LABEL, NON-RANDOMIZED, 2-PERIOD, FIXED SEQUENCE STUDY TO INVESTIGATE THE ABSORPTION, DISTRIBUTION, METABOLISM AND EXCRETION OF 14C-PF-06835919 AND TO ASSESS THE ABSOLUTE BIOAVAILABILITY AND FRACTION ABSORBED OF PF-06835919 IN HEALTHY MALE PARTICIPANTS USING A 14C-MICROTRACER APPROACH.

Withdrawn

• Conditions: a liver disease.; non-alcoholic steatohepatitis (NASH); 10019654

• Registration Number: NL-OMON49734
• Lead Sponsor: Pfizer Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 6

Inclusion Criteria

1. Male participants must be nonsmoking, 18 to <55 years of age, inclusive
2. Male participants who are overtly healthy as determined by medical
evaluation including medical history, physical examination, laboratory tests,
and cardiac tests.
3. Participants who are willing and able to comply with all scheduled visits,
treatment plan, laboratory tests, lifestyle considerations, and other study
procedures.
4. BMI of 17.5 to 30 kg/m2; and a total body weight >50 kg (110 lb).
5. Capable of giving signed informed consent

Exclusion Criteria

1. Evidence or history of clinically significant hematological, renal,
endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric,
neurological, or allergic disease (including drug allergies, but excluding
untreated, asymptomatic, seasonal allergies at the time of dosing).
2. Any condition possibly affecting drug absorption (eg, gastrectomy,
cholecystectomy,
appendectomy).
3. History of irregular bowel movements including irritable bowel syndrome or
frequent
episodes of diarrhea or constipation defined by less than 1 bowel movement on
average per 2 days or lactose intolerance.
4. History of HIV infection, hepatitis B, or hepatitis C; positive testing for
HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
5. 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
participant inappropriate for the study.
Further criteria apply, referring to protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Mass Balance: Cumulative recovery of radioactivity over time in urine, feces<br /><br>and total excreta (urine + feces) as percentage of total radioactive<br /><br>dose administered.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Metabolic profiling/metabolite identification and determination of relative<br /><br>abundance of 14C-PF-06835919 and metabolites in plasma, urine and feces (Period<br /><br>1).<br /><br>- PF-06835919 plasma (Period 1 and Period 2): Cmax, AUClast, Tmax, and if data<br /><br>permit, t*, AUCinf, CL/F, Vz/F.<br /><br>-14C-PF-06835919 plasma (Period 2): Cmax, AUClast, AUCinf, and if data permit,<br /><br>Tmax, t*, CL and Vss.<br /><br>-Total 14C radioactivity in plasma (Period 1): Cmax, AUClast, Tmax, t*.<br /><br>-PF-06835919 AUCinf from both oral PF-06835919 and IV 14C-PF-06835919 (Period 2<br /><br>only) plasma data.<br /><br>-Total 14C urine data following both IV (Period 2) and oral (Period 1)<br /><br>administration of 14C-PF-06835919 (quantification by AMS).<br /><br>-AE monitoring, physical examination, clinical laboratory measurements, vital<br /><br>signs and 12-lead ECG.</p><br>