NCT00960180

Brief Summary

This is a first-in-human study of MR1817. This study will provide an initial assessment of the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of MR1817 after administration of ascending single oral doses to healthy adult subjects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jul 2010

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

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

August 14, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 17, 2009

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

January 13, 2014

Status Verified

May 1, 2011

Enrollment Period

6 months

First QC Date

August 14, 2009

Last Update Submit

January 9, 2014

Conditions

Adult

Outcome Measures

Primary Outcomes (1)

  • Safety based on adverse event reporting, physical examinations, vital sign evaluations, 12-lead ECGs and routine laboratory tests

    6 weeks

Secondary Outcomes (1)

  • MR1817 plasma and urine concentration.

    6 weeks

Study Arms (2)

1

EXPERIMENTAL
Drug: MR1817

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

MR1817DRUG
1
PlaceboDRUG
2

Eligibility Criteria

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

You may qualify if:

  • Body mass index (BMI) in the range of 18 to 32 kg/m2 and body weight ≥50 kg. 3- Healthy as determined by the investigator on the basis of screening evaluations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Cambridge, CB23 2TN, United Kingdom

Location

Study Officials

  • Robert Miller

    Fulcrum Pharma (Europe) Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2009

First Posted

August 17, 2009

Study Start

July 1, 2010

Primary Completion

January 1, 2011

Study Completion

January 1, 2011

Last Updated

January 13, 2014

Record last verified: 2011-05

Locations

GB(1)