Multiple SclerosisPhase 1NCT02201849
A Study of ALKS 8700, a Monomethyl Fumarate (MMF) Molecule, in Healthy Adults
A Phase 1 study testing Study Drug in people with Multiple Sclerosis, run by Biogen at 1 site in United States.
Trial summary
This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Study Drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Dec 2014
- 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
- Has a body-mass Index (BMI) >/=18.0 and </=32.0 kg/m2
- Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration
- Additional criteria may apply
Who cannot join
- Is currently pregnant or breastfeeding
- Has a lifetime history of menopausal hot flashes
- Has a clinically significant medical condition
- Has had a clinically significant illness in the 30 days prior to first study drug administration
- Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to study drug administration
- Has had any vaccinations in the 4 weeks prior to inpatient admission
- Has a lifetime history of diabetes
- Additional criteria may apply
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults
This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule.
Read the detailed description
This study record was previously posted/updated by Alkermes, Inc. As of 29 Oct 2019, the sponsorship of the trial was transferred to Biogen along with responsibility for subsequent updates to the record.
- Conditions
- Multiple Sclerosis
- Being tested
- Study Drug, Active Control, Placebo
- Keywords
- Alkermes, ALKS 8700
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Study DrugDrug
Also called ALKS 8700 capsules
Active ControlDrug
Also called TECFIDERA® capsules
PlaceboDrug
Also called Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Study Drug | Experimental | Oral capsules Receives: Drug: Study Drug |
| Active Control | Active comparator | Oral capsules Receives: Drug: Active Control |
| Placebo | Placebo comparator | Oral capsules Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability will be measured by incidence of adverse events
Measured: up to 27 days
Secondary outcomes (4)
Maximum plasma concentration (Cmax)
Concentrations will be measured predose and at 0.25, 0.50, 1.00, 1.50, 2.00, 2.50, 3, 4, 6, 8, 10, 12, 24, 36, 48, and 72 hours postdose
Measured: up to 27 days
Time to attain Cmax (Tmax)
Measured: Up to 27 days
Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)
Measured: Up to 27 days
Area under the concentration-time curve from time 0 to infinity (AUCinf)
Measured: Up to 27 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by BiogenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biogen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Biogen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201849
- Sponsor's protocol ID
- ALK8700-001
- Status last verified
- Nov 2019
- First submitted
- 18 Jul 2014
- Last updated
- 26 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral ALKS 8700 in Healthy Adults
- ClinicalTrials.gov ID
- NCT02201849
- Acronym / sponsor ID
- ALK8700-001
- Conditions
- Multiple Sclerosis
- Keywords
- Alkermes, ALKS 8700
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- BiogenIndustry (pharma, biotech, devices)
- Study start
- Jul 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the safety, tolerability, and pharmacokinetics of ALKS 8700, a monomethyl fumerate (MMF) molecule.
Detailed description
This study record was previously posted/updated by Alkermes, Inc. As of 29 Oct 2019, the sponsorship of the trial was transferred to Biogen along with responsibility for subsequent updates to the record.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Study Drug | Experimental | Drug: Study DrugOral capsules |
| Active Control | Active comparator | Drug: Active ControlOral capsules |
| Placebo | Placebo comparator | Drug: PlaceboOral capsules |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Has a body-mass Index (BMI) >/=18.0 and </=32.0 kg/m2
- Agrees to use an acceptable method of contraception for the duration of the study and for 30 days after any study drug administration
- Additional criteria may apply
Key exclusion criteria (8 listed)
- Is currently pregnant or breastfeeding
- Has a lifetime history of menopausal hot flashes
- Has a clinically significant medical condition
- Has had a clinically significant illness in the 30 days prior to first study drug administration
- Has had a serious infection (eg, pneumonia or septicemia) within the 3 months prior to study drug administration
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Study DrugAlso: ALKS 8700 capsules | Drug | Study Drug |
| Active ControlAlso: TECFIDERA® capsules | Drug | Active Control |
| PlaceboAlso: Placebo capsules | Drug | Placebo |
Primary outcome
Safety and tolerability will be measured by incidence of adverse events
Time frame: up to 27 days
4 secondary outcomes
Maximum plasma concentration (Cmax)
Time frame: up to 27 days
Time to attain Cmax (Tmax)
Time frame: Up to 27 days
Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast)
Time frame: Up to 27 days
Area under the concentration-time curve from time 0 to infinity (AUCinf)
Time frame: Up to 27 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Biogen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Study Drug in people with Multiple Sclerosis, run by Biogen at 1 site in United States.
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 3 inclusion and 8 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 26 Nov 2019. 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 States. 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. Some participants in this study may receive a placebo. 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?
Safety and tolerability will be measured by incidence of adverse events (time frame: up to 27 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Nov 2019.