Multiple Sclerosis
Conditions
Keywords
Alkermes, ALKS 8700
Brief summary
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.
Interventions
Sponsors
Biogen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability will be measured by incidence of adverse events | up to 27 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum plasma concentration (Cmax) | up to 27 days | 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 |
| Time to attain Cmax (Tmax) | Up to 27 days | — |
| Area under the concentration-time curve from 0 to the last quantifiable time interval (AUClast) | Up to 27 days | — |
| Area under the concentration-time curve from time 0 to infinity (AUCinf) | Up to 27 days | — |
Countries
United States
Outcome results
None listed