Current partner codePEPTIDESDE
NCT03186495·Phase 1·INTERVENTIONAL

Investigation of Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Multiple Doses of Somapacitan in Subjects With Various Degrees of Impaired Renal Function Compared to Subjects With Normal Renal Function

Status

Completed

Phase

Phase 1

Enrollment

44

Locations

1

Results

Not posted

Publications

1

Study summary

What the protocol is testing.

The trial is conducted in Europe. The aim of the trial is to investigate the steady state exposure of somapacitan in subjects with various degrees of renal impairment (mild, moderate, severe renal impairment, requiring haemodialysis treatment) compared to subjects with normal renal function

Interventions

Treatment arms and agents.

DRUG

Somapacitan

All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan

Timeline

From registration to results.

  1. First posted

    Jun 14, 2017

  2. Study start

    Jun 20, 2017

  3. Primary completion

    May 17, 2018

  4. Study completion

    May 17, 2018

  5. Results posted

    Not reported

  6. Registry updated

    Apr 17, 2020

Outcomes

What the study measures.

Primary outcomes

Area under the somapacitan serum concentration time curve

Time frame · From time 0 to 168 hours after the last dosing on Day 15.

Calculated based on the serum concentrations measured in ug/l

Secondary outcomes

Maximum serum concentration of somapacitan

Time frame · After the last dosing on Day 15 up until Day 43

Measured in ng/ml

Time to maximum serum concentration of somapacitan

Time frame · After the last dosing on Day 15 up until Day 43

Calculated based on the serum concentrations measured in ug/l

Incidence of adverse events

Time frame · Day 0 - 43

Count and % of events

Occurrence of anti-somapacitan antibodies

Time frame · Day 0 - 43

Count or % of events

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
75 Years
Sex
ALL
Healthy volunteers
No

Inclusion Criteria: * Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent * Body mass index between 18.5-34.9 kg/sqm (both inclusive) * Meeting the pre-defined glomerular filtration rate for any of the renal function groups 1-4 (based on the measured glomerular filtration rate using exogenous sinistrin (Inutest®) as a filtration marker) or being in treatment with haemodialysis Exclusion Criteria: * Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measure as required by local regulation or practice). Male of reproductive age who or whose partner(s) is not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice) or male who is not willing to refrain from donating semen for at least 16 days after last trial product administration * Any disorder, except for conditions associated with renal impairment in the groups of subjects with reduced renal function, which in the investigator's opinion might jeopardise subject's safety, evaluation of results, or compliance with the protocol. For example, arterial hypertension, anaemia, impaired glucose tolerance or type 2 diabetes are accepted in the group of subjects with renal impairment

Study locations

1 registered sites.

Germany. Showing up to 24 locations stored in the fast local snapshot.

Novo Nordisk Investigational Site

Berlin, Germany

Related trials

More studies on Somapacitan.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.