NCT02130414

Brief Summary

The aim of this Phase I, single centre, multi stage study is to evaluate the safety, tolerability, pharmacokinetics and relative colonic mucosal concentrations of cyclosporine capsules (CyCol®) compared to intravenous cyclosporine in healthy male volunteers.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1 healthy

Timeline
Completed

Started Jul 2014

Typical duration for phase_1 healthy

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 5, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

May 19, 2015

Status Verified

May 1, 2015

Enrollment Period

6 months

First QC Date

April 22, 2014

Last Update Submit

May 18, 2015

Conditions

Healthy

Keywords

CyclosporineHealthy VolunteersImmunosuppressive AgentsCyColPharmacokinetics

Outcome Measures

Primary Outcomes (2)

  • Pharmacokinetic variables for cyclosporine (in whole blood)

    Area under the concentration-time curve (AUC) from; * time zero to the last non-zero concentration (AUC 0-t), * time zero extrapolated to infinity (AUC 0-inf), * maximum observed concentration (Cmax)

    Day 1 and Day 7

  • Concentrations (ng/g) of cyclosporine and its metabolites (AM1, AM9, AM4N) in colonic mucosa

    Concentrations (ng/g) of cyclosporine and its metabolites (AM1, AM9, AM4N)in colonic mucosal tissue

    Day 2 or Day 7

Secondary Outcomes (1)

  • Safety and Tolerability of CyCol

    Day 1 to Day 7

Other Outcomes (1)

  • Amount of unchanged cyclosporine and its metabolites excreted in faeces

    Day 1 through Day 7

Study Arms (4)

Sandimmun® IV

ACTIVE COMPARATOR

Sandimmun® IV 2mg/kg as a 24 hour infusion (2mg/kg/day)

Drug: Sandimmun® IV

CyCol® capsules

EXPERIMENTAL

CyCol®: 75 mg OD \& BID for 7 days

Drug: CyCol® capsules

CyCol® capsules 37.5 mg

EXPERIMENTAL

CyCol®: 37.5 mg OD or BID for 7 days

Drug: CyCol® capsules

CyCol® capsules, 150 mg

EXPERIMENTAL

CyCol®: 150 mg OD or BID for 7 days

Drug: CyCol® capsules

Interventions

Sandimmun® IVDRUG

2 mg/kg IV

Also known as: Cyclosporine A, Sandimmun® concentrate for solution for Infusion
Sandimmun® IV
CyCol® capsulesDRUG

37.5 mg CyCol® capsules

Also known as: Cyclosporine A, oral cyclosporine
CyCol® capsulesCyCol® capsules 37.5 mgCyCol® capsules, 150 mg

Eligibility Criteria

Age18 Years - 55 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male volunteers, between the ages of 18 and 55 years, inclusive.
  • Mass Index (BMI) of 18.5 to 30.0 kg/m2, inclusive; and a total body weight \>50 kg (110 lbs).
  • Subjects capable of providing written consent.
  • Subjects willing to use acceptable method of contraception starting from the first dose and continuing for at least 3 months after the last dose of study drug.
  • Subjects who are willing and able to comply with scheduled visits, dosing plan, laboratory tests, and other study procedures.
  • Subjects must have a regular bowel movement

You may not qualify if:

  • Any condition possibly affecting drug absorption (eg, gastrectomy).
  • A positive urine drug screen.
  • History of significant drug abuse
  • History of regular alcohol consumption
  • Treatment with an investigational drug within 90 days prior to first dose of study medication.
  • If considered clinically significant by the Investigator, screening supine blood pressure 140 mm Hg (systolic) or 90 mm Hg (diastolic), on a single measurement (confirmed by a single repeat, if necessary) following at least 5 minutes of rest.
  • lead ECG demonstrating QTcF interval \>450 msec or a QRS interval \>120 msec at Screening.
  • Use of medications :
  • prescription medications (oral and topical) within 14 days prior to first dosing.
  • over-the-counter products including herbal and food supplements within 7 days prior to first dose of study medication
  • injection or implant of any drug within 3 months prior to first dose of study medication
  • Use of any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior to administration of the study medication.
  • Plasma donation within 7 days prior to dosing.
  • History of sensitivity to cyclosporine or other related drugs.
  • Subjects with evidence of ongoing (active or carrier status) hepatitis B or C, or human immunodeficiency virus (HIV) infection upon serological testing.
  • +8 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

CyclosporineSolutions

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and ProteinsPharmaceutical Preparations

Study Officials

  • Sigmoid Pharma

    Sigmoid Pharma

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2014

First Posted

May 5, 2014

Study Start

July 1, 2014

Primary Completion

January 1, 2015

Study Completion

February 1, 2015

Last Updated

May 19, 2015

Record last verified: 2015-05