A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying … (NCT01578928) | Clinical Trial Compass
CompletedPhase 1
A Phase l Study to Evaluate the Pharmacokinetics and Safety Pasireotide in Subjects With Varying Degrees of Renal Impairment Compared to Healthy Volunteers
Germany, South Africa50 participantsStarted 2012-05
Plain-language summary
The purpose of this study is to assess the effect of renal impairment on the pharmacokinetics (PK) of pasireotide,the PK of pasireotide in subjects with different degrees of renal impairment.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Written informed consent obtained prior to any screening procedures.
✓. Subjects must be able to communicate well with the investigator and comply with the requirements of the study procedures
✓. Male or female subjects between 18 and 75 years of age, inclusive.
✓. Vital Signs at screening and baseline which are within the following ranges:
✓. Subjects must have a BMI between 20 kg/m2 and 30 kg/m2 and weigh at least 50 kg and no more than 120 kg.
✓. Subjects must be willing to comply with dietary, fluid, and lifestyle restrictions (from day-1 to study completion).
✓. Other than renal impairment, subjects must be stable and appropriately managed relative to chronic diseases (such as diabetes and hypertension) as determined by past medical history, physical examination, electrocardiogram, and laboratory tests for chemistry and hematology.
✓. Subjects must have stable renal disease without evidence of renal progressive disease (stable renal disease is defined as no significant change, such as, stable eGFR, for 12 weeks prior to study entry).
Exclusion criteria
✕. Clinically significant abnormal laboratory values at the screening evaluation or at the baseline re-evaluation, excluding those normally associated with mild to severe degree of renal impairment or the primary cause of renal insufficiency
✕. Use of any over-the-counter medications or vitamins or herbal/natural supplements during 2 weeks prior to dosing (acetaminophen is acceptable, and must be documented in the Concomitant Medications/Non-Drug Therapies page of the CRF)
What they're measuring
1
Plasma and Urine PK parameters
Timeframe: pre-dose (-1 min) and 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12, 24, 36, 48, 72, 96, 120 and 122 hours post-dose
✕. Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulation
✕. Donation or loss of 400 mL or more of blood within 8 weeks prior to dosing or other amount considered to compromise the health of the subject if previous history of anemia exists
✕. Significant acute illness within the two weeks prior to dosing
✕. History of immunocompromise, including a positive HIV (ELISA and Western blot) test result
✕. History of allergies to the investigational compound/compound class being used in the study