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. Author manuscript; available in PMC: 2017 Aug 1.
Published in final edited form as: J Clin Psychopharmacol. 2016 Aug;36(4):347–354. doi: 10.1097/JCP.0000000000000511

Table 1.

Ibudilast Phase I clinical trial within-subject crossover design study schema

Study Procedure Day Study Condition Description
Admission −2 Admit to Harbor-UCLA General Clinical Research Center
Randomization Randomization to ibudilast or placebo as 1st condition
Condition 1 1 – 3 ibudilast 20 mg BID or placebo Take study condition to achieve steady state
MA Challenge 15 mg 4 graphic file with name nihms774956t1.jpg MA 15 mg IV PM followed by cardiovascular, subjective effects, and PK draws
PK 5 PK draws
MA Challenge 30 mg 6 MA 30 mg IV PM followed by cardiovascular, subjective effects, and PK draws
PK 7 PK draws
Condition 2 8 – 10 ibudilast 50 mg BID or 20 mg BID Take study condition to achieve steady state
MA Challenge 15 mg 11 graphic file with name nihms774956t2.jpg MA 15 mg IV PM followed by cardiovascular, subjective effects, and PK draws
PK 12 PK draws
MA Challenge 30 mg 13 MA 30 mg IV PM followed by cardiovascular, subjective effects, and PK draws
PK 14 PK draws
Condition 3 15 – 17 placebo or ibudilast 50 mg BID Take study condition to achieve steady state
MA Challenge 15 mg 18 graphic file with name nihms774956t3.jpg MA 15 mg IV PM followed by cardiovascular, subjective effects, and PK draws
PK 19 PK draws
MA Challenge 30 mg 20 MA 30 mg IV PM followed by cardiovascular, subjective effects, and PK draws
PK 21 PK draws
MA Choice Session Sampling of MA 15 mg IV followed by choice of MA 15 mg IV or money
Washout 23 – 25 Inpatient washout. Monitor safety. Termination physical, labs, EKG
Discharge when stable
Health Check 14 day post-discharge safety check
*

abbreviations: twice-daily (BID); methamphetamine (MA); intravenous (IV); pharmacokinetics (PK); electrocardiogram (EKG)