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HealthyPhase 1NCT02551497

Study to Evaluate the Interaction Between a Drug and CNV1014802 in Healthy Subjects

A Phase 1 study testing CNV1014802 in people with Healthy, run by Biogen at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a double-blind, randomised, placebo-controlled 3 period study to evaluate the interaction between a drug and CNV1014802 in healthy male and female subjects. It is planned to enrol 36 subjects. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
CNV1014802
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteUnited Kingdom
Study dates
30 Apr 2015to 26 Aug 2016
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy males, or non-pregnant, non-lactating healthy females either of non-child bearing potential, or taking an approved method of contraception for the duration of the study
  • Age 18 to 55 years of age, inclusive
  • Non-smoking subjects with body weight ≥45 kg
  • Body mass index (BMI) of 18 to 32 kg/m2 (inclusive)
  • Must be willing and able to communicate and participate in the whole study
  • Must provide written informed consent
  • Must agree to use an adequate method of contraception

Who cannot join

  • Participation in a clinical research study within the previous 3 months
  • Subjects who are study site employees, or immediate family members of a study site or sponsor employee
  • Subjects who have previously been enrolled in this study
  • History of any drug or alcohol abuse in the past 2 years
  • History of regular alcohol consumption within 6 months of the study (male subjects >21 units per week or female subjects >14 units per week; 1 unit = ½ pint beer, 25 mL of 40% spirit or a 125 mL glass of wine)
  • Positive alcohol breath test
Show all 31Show fewer
  • Current smokers and those who have smoked within the last 6 months. A breath carbon monoxide reading of greater than 10 ppm at screening
  • Females of childbearing potential who are pregnant or lactating (female subjects must have a negative urine pregnancy test at admission)
  • Subjects who do not have suitable veins for multiple venepunctures/cannulation as assessed by the investigator at screening
  • Clinically significant abnormal biochemistry, haematology or urinalysis
  • Positive drugs of abuse test result
  • Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab) or human immunodeficiency virus (HIV) results
  • Positive genotyping test
  • History of cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease as judged by the investigator
  • Serious adverse reaction or serious hypersensitivity to any drug or the formulation excipients
  • Presence or history of clinically significant allergy requiring treatment, as judged by the investigator. Hayfever is allowed unless it is active
  • Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period
  • Subjects who are taking, or have taken, any prescribed or over-the-counter drug (other than hormone replacement therapy [HRT]/hormonal contraception not containing ethinyl estradiol) or herbal remedies in the 14 days before IMP administration
  • Significant medical history of fainting or vasovagal attacks
  • History of uncontrolled or poorly controlled hypertension
  • Semi-supine systolic BP <90 mmHg or >140 mmHg, or diastolic BP >100 mmHg after 3 assessments
  • QTcB or QTcF of >450 msec in male subjects or >470 msec in females
  • Presence or history of any clinically significant abnormality in vital signs or ECG
  • Presence of any medical condition, which in the opinion of the investigator may interfere with the study procedures or compromise subject safety
  • Medical history of clinically significant depression
  • History of suicide attempt within 6 months prior to screening
  • History of acute porphyria
  • History of cardiac conduction disorders with the exception of 1st degree heart block
  • Mentally or legally incapacitated
  • Unwillingness or inability to follow the procedures outlined in the protocol, or to comply with study restrictions on smoking, concomitant medications and diet
  • Failure to satisfy the investigator of fitness to participate for any other reason

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Research Site

    Nottingham

Other trials in United Kingdom

About this study

Official title: Double-Blind, Randomised, Placebo-Controlled, Parallel Group Study to Evaluate the Interaction Between a Drug and CNV1014802 in Healthy Subjects

This is a double-blind, randomised, placebo-controlled 3 period study to evaluate the interaction between a drug and CNV1014802 in healthy male and female subjects. It is planned to enrol 36 subjects.

Read the detailed description

This study was previously posted by Convergence Pharmaceuticals, Ltd., which has been acquired by Biogen.

Conditions
Healthy
Being tested
CNV1014802
Keywords
volunteer drug interaction study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CNV1014802Drug

Study groups in NCT02551497
Study groupRoleWhat they receive
Other drugExperimentalOther drug BID
Receives: Drug: CNV1014802
placeboExperimentalPlacebo to match BID
Receives: Drug: CNV1014802

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC(0-tau) of CNV1014802 and a drug

    Measured: days 1-28

  2. Cmax of CNV1014802 and a drug

    Measured: 5 days

  3. number of AEs

    Measured: Days 16 to 21

  4. heart rate

    Measured: Days16-21

  5. Blood pressure

    Measured: Days16-21

  6. ECG

    Measured: Days 16-21

  7. safety laboratory tests

    Measured: Days 16-21

Secondary outcomes (2)

  1. CNV1014802 Tmax

    Measured: days 1-28

  2. CNV1014802 Ctrough

    Measured: days 1-28

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2015 (estimated)
  2. Study start30 Apr 2015
  3. Primary completion16 Aug 2016
  4. Study completion26 Aug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02551497
Sponsor's protocol ID
1014802/102
Other IDs
2015-001926-41, 2015
Status last verified
Oct 2017
First submitted
7 Sep 2015
Last updated
16 Oct 2017
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CNV1014802 in people with Healthy, run by Biogen at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC(0-tau) of CNV1014802 and a drug (time frame: days 1-28). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02551497.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.

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