Single Dose Study With Unlabeled Dose and 14C-labeled Microdose of PF-06700841 in Healthy Male Subjects

NCT03770039 | Completed Phase 1 FDA Drug

• 2 other identifiers: B79310142018-002403-34
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

Brief Summary

An open-label, fixed sequence, 2-period including a single oral dose 60 mg PF-06700841 with 14C-labeled microtracer in 1st period, and a single oral dose of 60 mg unlabeled PF-06700841 followed by intravenous administration of 14C-labeled microdose of PF-06700841 1 hour after oral dose in period 2 to characterize the absorption, disposition, metabolism and excretion of PF-06700841 and evaluate the absolute bioavailability and fraction absorbed in the GI tract

Conditions

Healthy Male Subjects

Keywords

PF-06700841; mass balance; metabolites; absolute bioavailability

Outcome Measures

Primary Outcomes (2)

• mass balance_urine

  cumulative recovery of radioactivity over time in urine, as percentage of total radioactive dose administered

  hour 0 up to 312 hours post dose

• mass balance_feces

  cumulative recovery of radioactivity over time in feces, as percentage of total radioactive dose administered

  hour 0 up to 312 hours post dose

Secondary Outcomes (28)

• metabolite identification_plasma

  hour 0 up to 312 hours post dose

• plasma Cmax for total 14C radioactivity

  hour 0 up to 312 hours post dose

• plasma Tmax for total 14C radioactivity

  hour 0 up to 312 hours post dose

• plasma AUClast for total 14C radioactivity

  hour 0 up to 312 hours post dose

• plasma AUCinf for total 14C radioactivity

  hour 0 up to 312 hours post dose

Study Arms (1)

2-period, fixed sequence

EXPERIMENTAL

fixed sequence with 2 treatment period

Drug: Oral PF-06700841 containing 14C microtracer; Drug: Oral unlabeled PF-06700841; Drug: IV 14C-labeled PF-06700841

Interventions

Oral PF-06700841 containing 14C microtracer DRUG

Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period

2-period, fixed sequence

Oral unlabeled PF-06700841 DRUG

60 mg unlabeled PF-06700841 oral dose in 2nd period

2-period, fixed sequence

IV 14C-labeled PF-06700841 DRUG

30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period

2-period, fixed sequence

Eligibility Criteria

• Age: 18 Years - 55 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Any clinically significant malabsorption condition (eg, gastrectomy, bowel resection).
• Total 14C radioactivity measured in plasma exceeding 11 mBq/mL
• History of tuberculosis or active or latent or inadequately treated infection, positive QuantiFERON®-TB Gold test
• Use of tobacoo/nicotine containing products 3-m prior to dosing or positive urine cotinine test
• Use of herbal supplements within 28 days prior to the first dose of study medication
• Use of prescription or nonprescription drugs (including vitamins and dietary supplements) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication. As an exception, acetaminophen may be used at doses of 1 g/day. Limited use of non-prescription medications that are not believed to affect subject safety or the overall results of the study may be permitted on a case-by-case basis following approval by Pfizer
• Inability to have at least one bowel movement every 2 days on average eGFR of \<90 mL/mim/1.73 m2 based on MDRD equation
• Have been vaccinated with live or attenuated live vaccine within the 6 weeks prior to the first dose of investigational product, or expects to be vaccinated with these vaccines during study treatment, or within the 6 weeks following the last dose of investigational product.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (2)

PRA Health Sciences

Groningen, 9728 NZ, Netherlands

Location

PRA Health Sciences Utrecht

Utrecht, 3584 BL, Netherlands

Location

Related Publications (1)

• Qiu R, Sharma R, Wei H, Kirkovsky L, Zhou Y, Martin DDA, Banfield C, Dowty ME. A phase 1 study to investigate the absorption, distribution, metabolism and excretion of brepocitinib in healthy males using a 14 C-microdose approach. Br J Clin Pharmacol. 2023 Oct;89(10):3056-3066. doi: 10.1111/bcp.15786. Epub 2023 Jun 20.

  PMID: 37183779 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 10, 2018
• Study Start: December 10, 2018
• Primary Completion: February 21, 2019
• Study Completion: February 21, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)