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 range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Trial details

NCT IDNCT01578928

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-05

View on ClinicalTrials.gov More Renal Impairment trials