A Four-way Crossover Study of 3 Formulations of M207 With Intranasal Zolmitriptan in Healthy Volunteers

NCT03978403 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CP-2019-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, randomized, four-way crossover study. Subjects will receive the four study treatments once, followed by in-clinic monitoring and extensive pharmacokinetic analysis. Dosing occurs \~48 hours apart from patch application, in randomized order. Subjects will have final assessment and be dismissed from the study.

Conditions

Migraine

Keywords

Pharmacokinetics; Healthy; Volunteer

Outcome Measures

Primary Outcomes (3)

• Cmax

  maximum observed plasma concentration

  pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dose

• Adverse Events

  Subjects with treatment emergent adverse events

  48 hours

• Tmax

  Time to maximum concentration

  pre-dose, 2, 5, 10, 15, 20, 30, 45, 60, 90 minutes; 2, 4 , 8, 12, and 24 hours post-dose

Study Arms (4)

ABDC

EXPERIMENTAL

A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose

Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches); Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups); Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups; Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose

BCAD

EXPERIMENTAL

A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose

Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches); Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups); Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups; Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose

CDBA

EXPERIMENTAL

A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose

Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches); Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups); Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups; Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose

DACB

EXPERIMENTAL

A: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "Sled" coater packaged in foil pouches; B: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "MACAP" coater packaged in foil cups; C: M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min made on a "miniMac" coater packaged in foil cups; D: Zolmitriptan nasal 2.5 mg/0.1 mL single dose

Drug: M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches); Drug: M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups); Drug: M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups; Drug: Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose

Interventions

M207 3.8 mg "Sled" (two 1.9 mg patches made on a "Sled" coater, foil pouches) DRUG

M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "Sled" coater and packaged in foil pouches

Also known as: Treatment A

ABDC; BCAD; CDBA; DACB

M207 3.8 mg "MACAP" (two 1.9 mg patches made on a "MACAP" coater, foil cups) DRUG

M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "MACAP" coater and packaged in foil cups

Also known as: Treatment B

ABDC; BCAD; CDBA; DACB

M207 3.8 mg "MiniMac" (two 1.9 mg patches made on a "MiniMac" coater, foil cups DRUG

M207 3.8 mg administered as two 1.9 mg upper arm patches 30 min wear time made on a "miniMac" coater and packaged in foil pouches

Also known as: Treatment C

ABDC; BCAD; CDBA; DACB

Zolmitriptan 2.5 mg/0.1 mL nasal spray [ZOMIG] single dose DRUG

Zolmitriptan 2.5 mg/0.1 mL nasal spray \[ZOMIG\] single dose

Also known as: Treatment D, Zomig Nasal Spray

ABDC; BCAD; CDBA; DACB

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, complete blood count, blood chemistry, urinalysis, and ECG.
• Negative urine drug and alcohol screens and negative serum pregnancy tests (for female subjects) at screening and admission/baseline 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, hormonal contraceptives (subjects must be stable on hormonal contraceptives for at least 3 months prior to screening), surgical sterilization (hysterectomy, bilateral tubal ligation, 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
• Peripheral Vascular Disease
• 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 alanine transaminase \> 150 U/L, aspartate aminotransferase \> 130 U/L or bilirubin \> 2 times the upper limit of normal

Sponsors & Collaborators

• Zosano Pharma Corporation: lead

Study Sites (1)

Celerion

Tempe, Arizona, 85283, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Interventions

zolmitriptan; Nasal Sprays

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Aerosols; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Don Kellerman, Sr. VP, Clinical Development and Medical Affairs
• Organization: Zosano Pharma Corporation

dkellerman@zosanopharma.com

+1 (510) 745-4004

Study Officials

• Don Kellerman, PharmD

  Zosano Pharma Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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 four treatment sequences of four open-label treatments 48 hours apart.

Study Record Dates

• First Submitted: June 4, 2019
• First Posted: June 7, 2019
• Study Start: May 29, 2019
• Primary Completion: June 28, 2019
• Study Completion: June 28, 2019
• Last Updated: November 18, 2021
• Results First Posted: November 17, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)