A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007 AM1)



Status:Completed
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any
Updated:10/21/2012
Start Date:August 2012
End Date:February 2013
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase IIb, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine


The purpose of this study is to characterize the pharmacokinetics of MK-1602 in the
treatment of acute migraine, including the influence of demographic and other variables on
MK-1602 pharmacokinetics, and to evaluate the relationship between MK-1602 concentrations
and efficacy of the drug.


Inclusion Criteria:

- > 1 year history of migraine with or without aura as defined by International
Headache Society (IHS) criteria 1.1 and/or 1.2

- Migraines typically last between 4 to 72 hours, if untreated

- ≥ 2 and ≤ 8 moderate or severe migraine attacks per month in each of the two months
prior to screening

- Male, female who is not of reproductive potential, or female of reproductive
potential with a screening serum β-human chorionic gonadotropin (β-hCG) level
consistent with a not-pregnant state, and who agrees to use acceptable contraception

Exclusion Criteria:

- Pregnant or breast-feeding, or is a female expecting to conceive within the projected
duration of study participation

- Participant has difficulty distinguishing his/her migraine attacks from tension-type
headaches

- History of predominantly mild migraine attacks or migraines that usually resolve
spontaneously in less than two hours

- More than 15 headache-days per month or has taken medication for acute headache on
more than 10 days per month in any of the three months prior to screening

- Basilar-type or hemiplegic migraine headache

- > 50 years old at age of migraine onset

- Taking migraine prophylactic medication where the prescribed daily dose has changed
during the 3 months prior to screening and during the study

- Taking a proton pump inhibitor (PPI) or a histamine receptor 2 (H2) blocker on a
daily or near daily basis (> 3 days per week)

- Taking the following medications from 1 month prior to screening through study
period: potent cytochrome P450 (CYP) 3A4 inhibitors (e.g., cyclosporine,
itraconazole, ketoconazole, fluconazole, erythromycin, clarithromycin, nefazodone,
telithromycin, cimetidine, quinine, diltiazem, verapamil, modafinil and human
immunodeficiency virus [HIV] protease inhibitors), moderate or marked CYP3A4 inducers
(e.g., rifampicin, rifabutin, barbiturates [e.g., phenobarbital and primidone],
systemic glucocorticoids, nevirapine, efavirenz, pioglitazone, carbamazepine,
phenytoin, and St. Johns wort), or drugs with narrow therapeutic margins and
potential for drug interactions in the CYP2C family (e.g., warfarin)

- Participant is unable to refrain from consumption of grapefruit or grapefruit juice
during study

- History of hypersensitivity to, or has experienced a serious adverse event in
response to 3 or more classes of drugs (prescription and over-the-counter)

- Clinical or laboratory evidence of uncontrolled diabetes, HIV disease, or significant
pulmonary, renal, hepatic, endocrine, or other systemic disease

- Other confounding pain syndromes, psychiatric conditions such as uncontrolled major
depression, dementia or significant neurological disorders other than migraine.
Patients who are currently being treated with non-prohibited medication for
depression and symptoms are well controlled are eligible to participate

- Participant is at imminent risk of self-harm

- History of malignancy ≤ 5 years prior to study, except for adequately treated basal
cell or squamous cell skin cancer, or in situ cervical cancer

- History of gastric or small intestinal surgery (including gastric bypass surgery or
banding), or presence of a disease that causes malabsorption

- History or current evidence of any condition, therapy, lab abnormality or other
circumstance that might confound the results of the study, or interfere with
subject's participation for the full duration of the study

- Participant has recent history (within the last year) of drug or alcohol abuse or
dependence or is a user of recreational or illicit drugs

- Participant is legally or mentally incapacitated

- Donation of blood products or phlebotomy of > 300 ml within 8 weeks of study, or
intent to donate blood products or receive blood products within 30 days of screening
and throughout study

- Intent to donate eggs or sperm within the projected duration of the study

- Current participation in or participation within 30 days of screening in a study with
an investigational compound or device, with the exception of MK-1602 Protocol 006

- Previous exposure to MK-0974 and/or MK-3207

- Use within the past 2 months of an opioid- or barbiturate-containing analgesic for
migraine relief

- Inpatient or emergency department treatment of an acute migraine attack within the
past 2 months
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