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OpenTrials
Completed

NCT Number: NCT01638325

A Study of Insulin Lispro With BioChaperone Excipient in Healthy Participants

BC106 is a molecule that when injected with insulin lispro may change the speed of absorption of insulin lispro. The purpose of this study will be to evaluate the safety of BC106 insulin lispro and any side effects that might be associated with it, blood levels of insulin lispro after injection under the skin and how BC106 insulin lispro affects blood sugar after injection under the skin. There is a minimum 7 day washout between single doses.

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Key information

Conditions

Healthy Participants

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Singapore, 117597

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are not of child-bearing potential
  • Have a body mass index (BMI) between 18 and 29.9 kilograms per square meter (kg/m^2), inclusive
  • Are nonsmokers or have not smoked for at least 6 months prior to entering the study
  • Have a fasting plasma glucose less than 6.0 millimoles per liter (mmol/L) at screening

Exclusion criteria

  • Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin including allergies to dextrans
  • Have a history of first-degree relatives known to have diabetes mellitus
  • Have used systemic glucocorticoids within 3 months prior to entry into the study
  • Have donated or had a blood loss of 450 milliliters (mL) 3 months prior to study enrollment

Treatment and study plan

Insulin Lispro

Drug

Administered SC

Other names: Humalog, LY275585

BC106 insulin lispro

Drug

Administered SC

Other names: BioChaperone insulin lispro

Primary outcomes

  1. Pharmacokinetics: Area under the concentration curve (AUC)

    Time frame: Baseline up to 8 hours post administration of study drug

  2. Pharmacokinetics: Maximum concentration (Cmax)

    Time frame: Baseline up to 8 hours post administration of study drug

  3. Pharmacokinetics: Time of maximum concentration (Tmax)

    Time frame: Baseline up to 8 hours post administration of study drug

Secondary outcomes

  1. Glucodynamic response: Time to maximum infusion rate (tRmax) during euglycemic clamps of BC106 insulin lispro

    Time frame: Baseline up to 30 days

  2. Pharmacokinetics: Within-participant variability of time to maximum drug concentration (tmax) of BC106 insulin lispro

    Time frame: Baseline up to 30 days

  3. Glucodynamic within-participant variability of time to maximum glucose infusion rate (tRmax) for BC106 insulin lispro

    Time frame: Baseline up to 30 days

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Study to Assess the Pharmacokinetics, Glucodynamics, Safety, and Tolerability of Single Subcutaneous Injections of Insulin Lispro With BioChaperone Excipient in Healthy Volunteers

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Jul 11, 2012
Registry last updated
Jun 16, 2014

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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