A Study of M207 With Intranasal Zolmitriptan in Healthy Volunteers

NCT03708744 | Completed Phase 1 Results FDA Drug

• 1 other identifier: CP-2018-002
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single-center, open-label, randomized, four-way crossover study. Each subject will receive each of the four study treatments once, followed by in-clinic monitoring and extensive blood sample collection for pharmacokinetic analysis. Dosing will occur approximately 48 hours apart, until completion of dosing in randomized order per the treatment sequence tables. Plasma samples from the dosing days will be sent to the analytical laboratory for analysis and tolerability for each of the dose levels will be summarized. After completion of the four dosing days, subjects will be assessed one final time and dismissed from the study.

Conditions

Migraine

Keywords

Healthy; Volunteer; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Cmax

  maximum observed plasma concentration

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

Secondary Outcomes (2)

• Adverse Events

  24 hours

• t(1/2)

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

Study Arms (4)

Treatment A

EXPERIMENTAL

Treatment A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)

Drug: A: M207 3.8mg, 30 min, upper arm; Drug: B: M207 3.8 mg, 30 min, thigh; Drug: C: M207 3.8 mg, 1 hr, upper arm; Drug: D:zolmitriptan nasal spray

Treatment B

EXPERIMENTAL

Treatment B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)

Drug: A: M207 3.8mg, 30 min, upper arm; Drug: B: M207 3.8 mg, 30 min, thigh; Drug: C: M207 3.8 mg, 1 hr, upper arm; Drug: D:zolmitriptan nasal spray

Treatment C

EXPERIMENTAL

Treatment C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)

Drug: A: M207 3.8mg, 30 min, upper arm; Drug: B: M207 3.8 mg, 30 min, thigh; Drug: C: M207 3.8 mg, 1 hr, upper arm; Drug: D:zolmitriptan nasal spray

Treatment D

ACTIVE COMPARATOR

Treatment D: Intranasal zolmitriptan 2.5 mg

Drug: A: M207 3.8mg, 30 min, upper arm; Drug: B: M207 3.8 mg, 30 min, thigh; Drug: C: M207 3.8 mg, 1 hr, upper arm; Drug: D:zolmitriptan nasal spray

Interventions

A: M207 3.8mg, 30 min, upper arm DRUG

A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)

Also known as: A: Zolmitriptan patch, 3.8 mg, 30 min, upper arm

Treatment A; Treatment B; Treatment C; Treatment D

B: M207 3.8 mg, 30 min, thigh DRUG

B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)

Also known as: B: Zolmitriptan patch 3.8 mg, 30 min, thigh

Treatment A; Treatment B; Treatment C; Treatment D

C: M207 3.8 mg, 1 hr, upper arm DRUG

C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)

Also known as: C: Zolmitriptan patch, 3.8 mg, 1 hour, upper arm

Treatment A; Treatment B; Treatment C; Treatment D

D:zolmitriptan nasal spray DRUG

D: 2.5 mg/0.1 mL intranasal zolmitriptan

Also known as: Zomig Nasal Spray

Treatment A; Treatment B; Treatment C; Treatment D

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.
• Good general health with no clinically significant abnormalities as determined by medical history, physical examination, complete blood count (CBC), blood chemistry, urinalysis, and ECG.
• Negative urine drug and alcohol screens and negative serum pregnancy tests (for female subjects) at screening.
• 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), condom and vaginal spermicide, hormonal contraceptives (subjects must be stable on hormonal contraceptives for at least the prior 3 months), surgical 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 two or more risk factors for cardiovascular disease (family history of premature heart disease, hyperlipidemia, or hypertension)
• 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
• Uncontrolled hypertension
• Any history of hepatic impairment
• 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 screening through their last day of study participation
• Use of warfarin within 1 month prior to the first dose or heparin within 1 week prior to study drug administration
• Use of prescription and over the counter medications other than the following:
• Hormone Replacement Therapy (HRT)

Sponsors & Collaborators

• Zosano Pharma Corporation: lead

Study Sites (1)

Hill Top Research, Inc.

Neptune City, New Jersey, 07753, United States

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

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

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, Pharm.D.

  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: Randomized, open-label four-way crossover

Study Record Dates

• First Submitted: October 9, 2018
• First Posted: October 17, 2018
• Study Start: November 1, 2018
• Primary Completion: November 20, 2018
• Study Completion: November 20, 2018
• Last Updated: January 18, 2020
• Results First Posted: December 23, 2019

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)