PK & Tolerability of CNV1014802 in Young and Elderly Healthy Volunteers
A Randomized, Double-blind, Placebo Controlled, Two Period Crossover Study to Investigate the Pharmacokinetics, Tolerability and Cognitive Effects of an Oral Dose Regimen of 150mg Tid CNV1014802 in Healthy Young Versus Elderly Male and Female Subjects
2 other identifiers
interventional
32
1 country
1
Brief Summary
A randomized, double-blind, placebo controlled, two period crossover study to investigate the pharmacokinetics, tolerability and cognitive effects of 8 days dosing of CNV1014802 in healthy young versus elderly male and female subjects. Treatment periods will be separated by 13 days. The primary outcome measures are pharmacokinetics (PK) and tolerability.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Feb 2015
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 2, 2015
CompletedStudy Start
First participant enrolled
February 3, 2015
CompletedFirst Posted
Study publicly available on registry
February 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 20, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 20, 2015
CompletedOctober 12, 2017
October 1, 2017
3 months
February 2, 2015
October 10, 2017
Conditions
Outcome Measures
Primary Outcomes (7)
Maximum Concentration
9 days
Area under the concentration curve
9 days
Minimum concentration
9 days
Frequency of adverse events
9 days
Change in vital signs compared to baseline
9 days
Change in 12-lead ECG parameters compared to baseline
9 days
Change in safety lab parameters compared to baseline
9 days
Study Arms (2)
CNV1014802
EXPERIMENTALCNV1014802 150mg three times a day (tid) 7 days plus a single dose on day 8
Placebo
PLACEBO COMPARATORPlacebo tid 7 days plus a single dose on day 8
Interventions
Eligibility Criteria
You may qualify if:
- Healthy male and female over 18 years using acceptable methods of contraception
You may not qualify if:
- Positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody
- History or evidence of alcohol or drug abuse
- Pregnant or lactating females
- Participation in a clinical trial within 3 months or the current study or exposure to more than four new chemical entities within 12 months.
- Use of prohibited concomitant medication
- History or presence of any clinically significant abnormality in vital signs / ECG / laboratory tests, or have any medical or psychiatric condition, which, in the opinion of the Investigator may interfere with the study procedures or compromise subject safety.
- Relevant history of a suicide attempt or suicidal behavior
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (1)
Parexel International
London, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2015
First Posted
February 10, 2015
Study Start
February 3, 2015
Primary Completion
April 20, 2015
Study Completion
April 20, 2015
Last Updated
October 12, 2017
Record last verified: 2017-10