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Pharmacokinetics and Safety of Single Subcutaneous Pasireotide (SOM230) in Subjects With Varying Degrees of Hepatic Function
Plain-language guide to NCT00698464: phase 1 interventional trial of Pasireotide, 34 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00698464
- Phase
- phase 1
- Status
- completed
- Start
- 2008-07
- Completion (planned or actual)
- 2009-04
- Participants
- 34 (actual)
- Design
- na, open label (everyone knows who gets what), other
- Conditions studied
- Hepatic Cirrhosis; Alcoholism
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Pasireotide.
It had 1 arm (groups): Pasireotide (experimental).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 34 actual participants took part.
It was open to people of any sex aged from 18 years up to 75 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Male or female subjects between 18 and 75 years of age, inclusive. Vital signs at screening and baseline which are within normal ranges. Subjects must have a BMI between 20 kg/m2 and 30 kg/m2. Subjects with confirmed cirrhosis by at least one of the following criteria:. Histologically by prior liver biopsy showing cirrhosis.
The full record lists 6 inclusion and 20 exclusion criteria; among the exclusions: subjects with abnormal clinical laboratory values (except the clinical laboratory values linked to hepatic dysfunction); clinical evidence of liver disease or liver injury as indicated by abnormal liver function tests; A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result (antibody positive subjects will be allowed if non-viremic).
How the Study Was Run
It was run as a single-group and open-label study.
Nothing was hidden in this open-label Pasireotide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2008-07 with completion listed for 2009-04.
It ran at 4 sites in United States (1), Belgium (1), Germany (1) and South Africa (1).
Its stated primary purpose is other.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Pasireotide in 34 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Pasireotide compound page, all human trials.
Our Notes on the Compound
Pasireotide: An FDA-approved multi-receptor somatostatin analog for Cushing's disease and acromegaly; high blood sugar is a common side effect.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.