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NCT Number: NCT03235375

A Study to Evaluate Pharmacokinetics, Safety and Tolerability of MEDI0382 in Renal Impairment Subjects

A phase 1 open-label, single-dose study to evaluate the pharmacokinetics (PK), safety, tolerability and immunogenicity of MEDI0382 in subjects with renal impairment.

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Key information

Conditions

Renal Insufficiency Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site, Kiel, Germany

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About this study

This is an open-label, single-dose, parallel group study to evaluate the PK, safety, tolerability, and immunogenicity of MEDI0382 in subjects with renal impairment. Enrollment of approximately 40 subjects across multiple sites is planned. Subjects will be divided into 4 groups based on renal function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must provide written informed consent
  • BMI greater than or equal to 17 and less than or equal to 40 kg/m2
  • Creatinine clearance rate greater than or equal to 90 (healthy); or renally impaired (less than 60 mL/min)
  • Females of childbearing potential must use a highly effective form of contraception.

Exclusion criteria

  • Any history of or concurrent condition that in the opinion of the investigator would compromise the subjects safety.
  • Subjects on dialysis
  • Subjects with pancreatitis
  • Renal transplant subjects
  • Females pregnant or lactating

Treatment and study plan

MEDI0382

Drug

MEDI0382 administered subcutaneously

Primary outcomes

  1. Maximum Observed Concentration of MEDI0382 (Cmax)

    Time frame: 0-48 hours

    The first occurrence of the maximum observed plasma concentration determined directly from the raw concentration-time data

  2. Area under the Concentration Time Curve (AUC) of MEDI0382

    Time frame: 0-48 hours

    The area under the plasma concentration-time curve to 48 hours concentration determined using the linear trapezoidal rule for increasing concentrations and the logarithmic trapezoidal rule for decreasing concentrations

Secondary outcomes

  1. Time to maximum observed concentration (Tmax)

    Time frame: 0-48 hours

    Time to maximum observed concentration.

  2. apparent clearance (Cl/F)

    Time frame: 0-48 hours

    The apparent clearance will be calculated as CL/F=Dose/AUC(0-inf)

  3. AUCinf

    Time frame: 0-48 hours

    The AUC extrapolated to infinity will be calculated, where data permit, as the sum of AUC((0-t) and Ct/z, where Ct is the observed plasma concentration obtained from the log-linear regression analysis of the last quantifiable time-point and z is the terminal phase rate constant.

  4. Half-life (T1/2)

    Time frame: 0-48 hours

    The apparent terminal elimination half-life (t1/2) obtained as the ratio of ln2/z, where z is the terminal phase rate constant estimated by linear regression analysis of the log transformed concentration-time data

  5. Anti-drug Antibody (ADA) titer

    Time frame: Day -1 to day 28

    ADA titer through to day 28

  6. Number of subjects with Adverse Events

    Time frame: Study onset till 28 days post dosing

    Treatment emergent adverse events (TEAEs) and serious adverse events (TESAEs)

  7. Number of subjects with Adverse Events

    Time frame: Study onset till 28 days post dosing

    Vital Signs (systolic and diastolic blood pressure, pulse rate, temperature and respiratory rates)

  8. Number of subjects with Adverse Events

    Time frame: Study onset till 28 days post dosing

    Clinical laboratory assessments (serum chemistry, hematology, and urinalysis)

Sponsors and collaborators

Lead sponsor

MedImmune LLC

Industry

Registry information

Official study title

A Phase 1, Open-Label, Single Dose, Parallel-Group Study to Evaluate the Pharmacokinetics, Safety and Tolerability of MEDI0382 in Subjects With Renal Impairment

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 1, 2017
Registry last updated
May 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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