Study of PK, Safety, and Tolerability of 2 Lots of M207 & Intranasal Zolmitriptan in Healthy Volunteers

NCT04969497 | Completed Phase 1 FDA Drug

• 1 other identifier: CP-2021-001
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, randomized, 3-way crossover study. Each subject will receive each of the three study treatments once, followed by in-clinic monitoring and extensive blood sample collection for plasma PK analysis. Dosing will occur at least 48 hours apart from the time of patch application, until completion of dosing in randomized order per the treatment sequence schedule. After completion dosing, subjects will be assessed one final time.

Conditions

Migraine

Keywords

Pharmacokinetics; Healthy; Volunteer

Outcome Measures

Primary Outcomes (3)

• Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

  Incidence and type of adverse events reported and observed

  24 hours

• Cmax

  Maximum observed plasma concentrations

  24 hours

• Tmax

  Time in hours to maximum concentration assessed over 24 hours

  24 hours

Study Arms (6)

Sequence ABC

EXPERIMENTAL

Receives interventions in the sequence, A, B, C.

Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0

Sequence CAB

EXPERIMENTAL

Receives interventions in the sequence, C, A, B.

Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0

Sequence BCA

EXPERIMENTAL

Receives interventions in the sequence, B, C, A.

Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0

Sequence CBA

EXPERIMENTAL

Receives interventions in the sequence, C, B, A.

Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0

Sequence BAC

EXPERIMENTAL

Receives interventions in the sequence, B, A, C.

Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0

Sequence ACB

EXPERIMENTAL

Receives interventions in the sequence, A, C, B.

Drug: Treatment A: M207 3.8 mg "MiniMac"; Drug: Treatment B: M207 3.8 mg "MACAP"; Drug: Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0

Interventions

Treatment A: M207 3.8 mg "MiniMac" DRUG

Treatment A: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a "MiniMac" coater and packaged in foil cups

Also known as: MiniMac, M207

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

Treatment B: M207 3.8 mg "MACAP" DRUG

Treatment B: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a "MACAP" coater and packaged in foil cups

Also known as: MACAP, M207

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0 DRUG

Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0

Also known as: Zomig

Sequence ABC; Sequence ACB; Sequence BAC; Sequence BCA; Sequence CAB; Sequence CBA

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women or men 18 to 50 years of age (inclusive)
• Good general health with no clinically significant abnormalities as determined by medical history, physical examination, CBC, blood chemistry, urinalysis, and ECG.
• Negative serum pregnancy tests (for female subjects) at the screening and admission visit.
• Consent of female subjects to use a medically effective method of contraception throughout the entire study period and for 30 days after the subject completes the study. Medically effective methods of contraception that may be used by the subject include abstinence, use of diaphragm and spermicide, intrauterine device (IUD), rings, condom and vaginal spermicide, non-oral hormonal contraceptives (subjects must be stable on non-oral hormonal contraceptives for at least 3 months prior to screening), surgical sterilization (hysterectomy, bilateral tubal ligation or oophorectomy, hysteroscopic sterilization) and post-menopausal (≥ 2 years of amenorrhea).
• Ability to read, understand, and provide written informed consent that they understand the purpose of the study and procedures required for the study before enrolling in the study, and willingness to comply with all study procedures and restrictions.

You may not qualify if:

• Evidence of significant history of hepatic, reproductive, gastrointestinal, renal, bleeding, or hematological disorders including coagulation, pulmonary, neurological, respiratory, endocrine, or cardiovascular system abnormalities (especially hypertension, peripheral vascular disease, coronary artery disease, transient ischemic attacks, or cardiac rhythm abnormalities), psychiatric disorders, acute infection, or other conditions that would interfere with study participation or with the absorption, distribution, metabolism, or excretion of drugs.
• Presence of three or more of the following CAD risk factors for cardiovascular disease:
• A. Current tobacco use (subjects who have smoked within 30 days of screening) B. Hypertension (systolic BP \> 140 or diastolic BP \> 90) or receiving anti-hypertensive medication for treatment of hypertension C. Hyperlipidemia - LDL \> 159 mg/dL and/or HDL \< 40 mg/dL (or on prescribed anti-cholesterol treatment) D. Family history of premature coronary artery disease (CAD) (\< 55 years of age in male first-degree relatives or \< 65 years of age in female first degree relatives) E. Diabetes mellitus
• Any contraindication to zolmitriptan administration including:
• History of coronary artery disease or coronary vasospasm
• Symptomatic Wolf-Parkinson-White syndrome or other cardiac accessory conduction pathway disorders
• History of stroke, transient ischemic attack, or hemiplegic or basilar migraine
• History or current Peripheral Vascular Disease
• History or current Ischemic bowel disease
• Hypertension (greater than or equal to 140/90 mmHg at either the screening or admission/baseline visit
• Any history of hepatic impairment defined as ALT \> 150 U/L, AST \> 130 U/L or bilirubin \> 2 times the ULN
• History of contact dermatitis or known dermatological disorders that would interfere with the study procedures or assessments
• Planned participation in activities which cause inflammation, irritation, sunburn, lesions, or tattoos at the intended application sites from 2 weeks prior to dosing through the duration of the trial
• Use of any prescription anticoagulant within 30 days prior to the first dose through the duration of the trial
• Use of prescription and over the counter medications within one week of dosing other than the following:

Sponsors & Collaborators

• Zosano Pharma Corporation: lead

Study Sites (1)

Worldwide Clinical Trials

San Antonio, Texas, 78217, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

zolmitriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Don Kellerman, PharmD

  Zosano Pharma Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects are randomized to receive one of six treatment sequences of three open-label treatments 48 hours apart.

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 20, 2021
• Study Start: June 24, 2021
• Primary Completion: September 2, 2021
• Study Completion: September 2, 2021
• Last Updated: September 17, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)