Bioavailability Study to Compare OPTINOSE SUMATRIPTAN With IMITREX® in Healthy Subjects

NCT01507610 | Completed Phase 1

• 1 other identifier: OPN-SUM-1302
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is:

• To compare the single-dose pharmacokinetics (PK) of intranasal administration of 20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.
• To estimate the relative bioavailability of single-dose intranasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to a single-dose of 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.

Conditions

Migraine

Keywords

sumatriptan; bioavailability

Outcome Measures

Primary Outcomes (2)

• The pharmacokinetic parameters of sumatriptan following the administration of OPTINOSE SUMATRIPTAN and IMITREX® (sumatriptan).

  The pharmacokinetic parameters AUC0-∞ and Cmax of sumatriptan following the administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection. • The relative bioavailability (Frel) of sumatriptan following the nasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to 6 mg IMITREX® (sumatriptan) Subcutaneous Injection.

  Measurement of pharmacokinetic parameters of sumatriptan at pre-treatment and at: 2, 5, 10, 15, 20, 25, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post treatments.

• Bioavailability of sumatriptan following the administration of OPTINOSE SUMATRIPTAN and IMITREX® (sumatriptan).

  The relative bioavailability (Frel) of sumatriptan following the nasal administration of 20 mg OPTINOSE SUMATRIPTAN, 20 mg IMITREX® (sumatriptan) Nasal Spray, and 100 mg IMITREX® (sumatriptan) Oral Tablet compared to 6 mg IMITREX® (sumatriptan) Subcutaneous Injection.

  Measurement of plasma sumatriptan concentrations at pre-treatment and at: 2, 5, 10, 15, 20, 25, 30, 45 minutes, and 1, 1.5, 2, 3, 4, 6, 8, 10, 12 and 14 hours post treatments.

Secondary Outcomes (2)

• Sensory attributes of the intranasal OPTINOSE SUMATRIPTAN product and IMITREX® (sumatriptan).

  Sensory attributes will be evaluated within 2 minutes after drug administration. The evaluation will be repeated within 5 to 10 minutes after drug administration.

• Safety Evaluations of the intranasal OPTINOSE SUMATRIPTAN product and IMITREX®

  Safety evaluations will be perfromed on days 1, 8, 15, 22, 25 and 32

Study Arms (4)

Investigational

EXPERIMENTAL

OPTINOSE SUMATRIPTAN, single dose of 20 mg intranasally (10 mg to each nostril).

Drug: Sumatriptan

IMITREX Nasal Spray

ACTIVE COMPARATOR

IMITREX® (sumatriptan) Nasal Spray, single dose of 20 mg intranasally (20 mg to one nostril).

Drug: Sumatriptan

IMITREX Oral Tablet

ACTIVE COMPARATOR

IMITREX® (sumatriptan) Oral Tablet, single dose of 100 mg, administered orally with 240 mL water.

Drug: Sumatriptan

IMITREX Subcutaneous Injection

ACTIVE COMPARATOR

IMITREX® (sumatriptan) Subcutaneous Injection, single dose of 6 mg injected subcutaneously in the abdomen.

Drug: Sumatriptan

Interventions

Sumatriptan DRUG

To compare the single-dose pharmacokinetics (PK) and relative bioavailability of intranasal administration of 20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.

IMITREX Nasal Spray; IMITREX Oral Tablet; IMITREX Subcutaneous Injection; Investigational

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men or women ages 18 to 55 years, inclusive, at screening.
• Healthy with no clinically relevant abnormalities in the opinion of the Investigator as determined by medical history, physical examination, blood chemistry, hematology, including complete blood count, urinalysis, vital signs, and ECG.
• Have a BMI of 18-32 kg/m2, inclusive, and a body weight of not less than 50 kg.
• For females of childbearing potential: either be sexually inactive (abstinent) for 14 days prior to the first dose and throughout the study or be using one of the following acceptable birth control methods:
• intrauterine device in place for at least 3 months prior to the first dose and throughout the study.
• barrier methods (condom, diaphragm) with spermicide for at least 14 days prior to the first dose and throughout the study.
• surgical sterilization of the partner (vasectomy for 6 months minimum).
• hormonal contraceptives for at least 3 months prior to the first dose of the study and throughout the study.
• Female subjects who claim to be sexually inactive, but become sexually active during the course of the study must agree to use a barrier method (e.g. condom, diaphragm) with spermicide from the time of the start of sexual activity through completion of the study.
• In addition, female subjects of childbearing potential will be advised to remain sexually inactive or to keep the same birth control method for the whole duration of the study.
• Females of non-childbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to Day 1:
• bilateral tubal ligation
• hysterectomy
• bilateral oophorectomy or be postmenopausal with amenorrhea for at least 1 year prior to Day 1 and follicle stimulating hormone (FSH) serum levels ≥ 40 mIU/mL.
• Women of child-bearing potential must have a negative serum beta-human chorionic gonadotropin at the screening visit and at each check-in prior to dosing.

You may not qualify if:

• Currently have or have a history of disease or dysfunction of the pulmonary, cardiovascular, endocrine, hematologic, neurological, immune, gastrointestinal, genitourinary, or other body system that is clinically significant in the opinion of the Investigator.
• Have evidence of any chronic medical conditions requiring prescription medications (eg, hypertension or diabetes).
• Have a history of migraines.
• History of hypersensitivity or allergies to any drug compound, including sumatriptan, any of its components or sulphonamides.
• Have had a major or traumatic surgery within 12 weeks prior to screening, pre-planned surgery or procedures that would interfere with the conduct of the study.
• Have an acute illness within 7 days prior to study agent administration or have had a major illness or hospitalization within 1 month prior to study agent administration.
• Have clinically significant findings on screening ECG.
• Have a recent history (within 1 previous year) of alcohol or drug abuse.
• History of smoking or use of nicotine-containing substances within the previous 2 months.
• Have abnormal values for hematology, clinical chemistry, or urinalysis at screening or check-in considered clinically significant by the Investigator.
• Have a positive serology test for HIV antibodies, HBsAg, or hepatitis C virus antibody (anti-HCV) at screening.
• Have a positive urine drug screen for ethanol or substances of abuse including cocaine, cannabinoids, phencyclidine, amphetamines, benzodiazepines, barbiturates, opiates, propoxyphene, and methadone at screening and each check-in.
• Have a haemoglobin level below the lower limit of normal at screening.
• Have donated blood or experienced significant blood loss (volume \> 500 mL) within 3 months prior to screening, or is planning to donate within 2 months after completion of the study.
• Use of drug metabolizing enzyme (CYP-450) inducers within 28 days prior to dosing or inhibitors within 14 days prior to dosing (refer to Appendix 1).

Sponsors & Collaborators

• Optinose US Inc.: lead

Study Sites (1)

Celerion

Neptune City, New Jersey, 07753, United States

Location

Related Publications (1)

• Obaidi M, Offman E, Messina J, Carothers J, Djupesland PG, Mahmoud RA. Improved pharmacokinetics of sumatriptan with Breath Powered nasal delivery of sumatriptan powder. Headache. 2013 Sep;53(8):1323-33. doi: 10.1111/head.12167. Epub 2013 Aug 28.

  PMID: 23992438 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Sumatriptan

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

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

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 11, 2012
• Study Start: January 1, 2012
• Primary Completion: February 1, 2012
• Study Completion: February 1, 2012
• Last Updated: February 29, 2012

Record last verified: 2012-01

Locations

US (1)