A Pharmacokinetic Study of MK-1602 in the Treatment of Acute Migraine (MK-1602-007)
Condition: Migraine
MeSH terms: Migraine Disorders
Intervention: MK-1602; Placebo; Rescue medication
Intervention description: Three administrations of the same dose of MK-1602 on separate days. All 3 doses are either 1, 10, 25, 50 or 100 mg of MK-1602. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1).
Dosage form is film coated tablet for oral administration.; Three administrations of placebo for MK-1602 on separate days. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1).
Dosage form is film coated tablet for oral administration.; If moderate or severe migraine headache pain continues 2 hours after dose of study medication or if migraine headache comes back within 48 hours,
Participants will be allowed to take their own rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs]), anti-emetics, triptans, opiates or other medication not explicitly excluded.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 195.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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