Safety and Blood Level Study of Unit Dose Budesonide

NCT00627679 | Completed Phase 1 Results

• 1 other identifier: MAP0010-CL-P101
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the tolerability and pharmacokinetics of three doses of MAP0010 (Unit Dose Budesonide) compared with Pulmicort Respules® (Budesonide) in healthy volunteers.

Conditions

Asthma

Keywords

Pediatric asthma

Outcome Measures

Primary Outcomes (5)

• Cmax of of Budesonide After Administration of Pulmicort and Three Dose Levels of MAP0010

  The maximum concentration (Cmax) is the highest concentration of a drug measured in the plasma. Plasma is the clear portion of the blood. The Cmax of Budesonide is reported in picograms per milliliter (pg/ml).

  8 hours

• Tmax of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010

  Tmax is the time to maximum concentration of a drug in the plasma. The Tmax of budesonide is reported in minutes (min).

  8 hours

• AUC(0-8) of Budesonide After Administration of Pulmicort Respules® and Three Doses of MAP0010

  The AUC(0-8) is the area under the plot of plasma concentration of drug against time after drug administration. Budesonide AUC(0-8) is reported in picograms times minutes per milliliter (pg\*min/ml).

  8 hours

• AUC(0-inf) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010

  The AUC(0-inf) is the area under the plot of plasma concentration of drug against time to infinity (inf) after drug administration. Budesonide AUC(0-inf) is reported in picograms times minutes per milliliter (pg\*min/ml).

  8 hours

• Half-life (t1/2) of Budesonide After Administration of Pulmicort Respules® and Three Dose Levels of MAP0010

  Half-life (t1/2) is the time for the drug to decrease to half of its maximum concentration. Budesonide t1/2 is reported in minutes (min).

  8 hours

Study Arms (4)

Treatment sequence: A, B, D, C

EXPERIMENTAL

Treatment visits were separated by a 48-72 hour washout period. Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 2; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 3; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 4; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 5

Drug: Budesonide Inhalation Suspension; Drug: MAP0010 low dose; Drug: MAP0010 intermediate dose; Drug: MAP0010 high dose

Treatment sequence: B, C, A, D

EXPERIMENTAL

Treatment visits were separated by a 48-72 hour washout period. Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 2; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 3; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 4; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 5

Drug: Budesonide Inhalation Suspension; Drug: MAP0010 low dose; Drug: MAP0010 intermediate dose; Drug: MAP0010 high dose

Treatment sequence: C, D, B, A

EXPERIMENTAL

Treatment visits were separated by a 48-72 hour washout period. Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 2; Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 3; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 4; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 5

Drug: Budesonide Inhalation Suspension; Drug: MAP0010 low dose; Drug: MAP0010 intermediate dose; Drug: MAP0010 high dose

Treatment sequence: D, A, C, B

EXPERIMENTAL

Treatment visits were separated by a 48-72 hour washout period. Treatment D = a single dose of MAP0010 high dose delivered by nebulization at Visit 2; Treatment A = a single dose of Budesonide inhalation suspension (Pulmicort Respules®) delivered by nebulization at Visit 3; Treatment C = a single dose of MAP0010 intermediate dose delivered by nebulization at Visit 4; Treatment B = a single dose of MAP0010 low dose delivered by nebulization at Visit 5

Drug: Budesonide Inhalation Suspension; Drug: MAP0010 low dose; Drug: MAP0010 intermediate dose; Drug: MAP0010 high dose

Interventions

Budesonide Inhalation Suspension DRUG

Treatment A = a single dose of Pulmicort Respules® (budesonide inhalation suspension) delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

Also known as: Pulmicort Respules®

Treatment sequence: A, B, D, C; Treatment sequence: B, C, A, D; Treatment sequence: C, D, B, A; Treatment sequence: D, A, C, B

MAP0010 low dose DRUG

Treatment B = a single dose of MAP0010 (unit dose budesonide) low dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

Treatment sequence: A, B, D, C; Treatment sequence: B, C, A, D; Treatment sequence: C, D, B, A; Treatment sequence: D, A, C, B

MAP0010 intermediate dose DRUG

Treatment C = a single dose of MAP0010 (unit dose budesonide) intermediate dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

Treatment sequence: A, B, D, C; Treatment sequence: B, C, A, D; Treatment sequence: C, D, B, A; Treatment sequence: D, A, C, B

MAP0010 high dose DRUG

Treatment D = a single dose of MAP0010 (unit dose budesonide) high dose delivered by nebulization at Visit 2, 3, 4, or 5 as per protocol.

Treatment sequence: A, B, D, C; Treatment sequence: B, C, A, D; Treatment sequence: C, D, B, A; Treatment sequence: D, A, C, B

Eligibility Criteria

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

You may qualify if:

• Healthy adult volunteers, aged 18-50 years
• BMI less than 30 kg/m2
• Non smoker (currently and \<10 pack years total if ex-smoker)

You may not qualify if:

• Any use of corticosteroid in previous 4 weeks
• Pregnancy/lactation
• Significant blood donation (or testing) in previous 8 weeks

Sponsors & Collaborators

• Allergan: lead
• MAP Pharmaceuticals, Inc., a wholly owned subsidiary of Allergan: collaborator
• Q-Pharm Pty Limited: collaborator

Study Sites (1)

Q-Pharm Pty Limited

Brisbane, Queensland, QLD 4006, Australia

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: VP, Scientific Affairs
• Organization: MAP Pharmaceuticals Inc., a wholly owned subsidiary of Allergan

dkellerman@mappharma.com

(650) 386-3100

Study Officials

• Joanne Marjason, MBBS

  Q-Pharm Pty Limited

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2008
• First Posted: March 3, 2008
• Study Start: December 1, 2005
• Primary Completion: December 1, 2005
• Study Completion: May 1, 2006
• Last Updated: January 9, 2014
• Results First Posted: October 23, 2013

Record last verified: 2013-12

Locations

AU (1)