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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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28 December 2015 |
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Main ID: |
NCT02534740 |
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Date of registration:
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25/08/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study Comparing Amounts of Tafamidis In The Blood With Or Without Food
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Scientific title:
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A Phase 1, Open-Label, Randomized, Single Dose Study To Estimate The Relative Bioavailability And Food Effect Of PF-06291826 (Tafamidis) Following Administration Of New Soft Gelatin Capsule Oral Formulations In Healthy Subjects |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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18 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02534740 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science
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Phase:
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Phase 1
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Countries of recruitment
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Belgium
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Healthy males or females of non-child bearing potential.
- Body Mass Index (BMI) of 17.5 to 30.5 and total body weight more than 50 kg (110
lbs).
Exclusion Criteria:
- Blood pressure at screening visit of greater than 140 mm Hg (systolic) or 90 mg Hg
(diastolic).
- Use of prescription or nonprescription drugs supplements within 7 days prior to 7
days of the study.
- Pregnant female subjects; breastfeeding female subjects; male subjects with partners
currently pregnant; male subjects able to father children who are unwilling or unable
to use a highly effective method of contraception.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Healthy
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Intervention(s)
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Drug: tafamidis
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Primary Outcome(s)
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Maximum Observed Plasma Concentration (Cmax)
[Time Frame: 120 hours]
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Area under the concentration-time Curve (AUC)
[Time Frame: 120 hours]
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Secondary Outcome(s)
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Plasma Decay Half-Life (t1/2)
[Time Frame: 120 hours]
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Area Under the Curve from Time zero to infinity
[Time Frame: 120 hours]
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Time to Reach Maximum Observed Plasma Concentration (Tmax)
[Time Frame: 120 hours]
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Area Under the Curve From Time Zero to Last Quantifiable Concentration (AUClast)
[Time Frame: 120 hours]
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Secondary ID(s)
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2015-002315-15
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B3461052
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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