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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.

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. - A Phase 1 ADME Study of 14C-PF-06835919 in Healthy Male Participants.

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON49734
Enrollment
6
Registered
2020-08-17
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

a liver disease. non-alcoholic steatohepatitis (NASH)

Interventions

In Period 1 on Day 1, the volunteers will be given 300 mg of 14C-labeled PF-06835919 as an oral suspension of 100 mL. After administration of the study compound, the vial will be rinsed 3 times with

Sponsors

Pfizer Inc.
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Male participants must be nonsmoking, 18 to 50 kg (110 lb). 5. Capable of giving signed informed consent

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
Mass Balance: Cumulative recovery of radioactivity over time in urine, feces and total excreta (urine + feces) as percentage of total radioactive dose administered.—

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)